Delivery of respiratory therapy

ABSTRACT

A patient interface includes a sealing arrangement adapted to provide an effective seal with the patient&#39;s nose, an inlet conduit arrangement adapted to deliver breathable gas to the sealing arrangement, and a cover that substantially encloses the sealing arrangement and/or the inlet conduit arrangement.

CROSS-REFERENCE TO APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 60/833,841, filed Jul. 28, 2006, which is incorporatedherein by reference in its entirety.

FIELD OF THE INVENTION

The invention relates to the delivery of respiratory therapy to apatient. Examples of such therapies are Continuous Positive AirwayPressure (CPAP) treatment, Non-Invasive Positive Pressure Ventilation(NIPPV), and Variable Positive Airway Pressure (VPAP). The therapy isused for treatment of various respiratory conditions including SleepDisordered Breathing (SDB) such as Obstructive Sleep Apnea (OSA).

BACKGROUND OF THE INVENTION

Typically, respiratory therapy is delivered in the form of a mask systempositioned between a patient and apparatus providing a supply ofpressurized air or breathing gas. Mask systems in the field of theinvention differ from mask systems used in other applications such asaviation and safety in particular because of their emphasis on comfort.This high level of comfort is desired because patients must sleepwearing the masks for hours, possibly each night for the rest of theirlives. In addition, therapy compliance can be improved if the patient'sbed partner is not adversely affected by the patient's therapy andwearing of the mask generally.

Mask systems typically, although not always, comprise (i) a rigid orsemi-rigid portion often referred to as a shell or frame, (ii) a soft,patient contacting portion often referred to as a cushion, and (iii)some form of headgear to hold the frame and cushion in position. If themask system does in fact include multiple components, at least someassembly and adjustment may be required, which can be difficult forpatients who may suffer from lack of dexterity, etc. Further, masksystems often include a mechanism for connecting an air deliveryconduit. The air delivery conduit is usually connected to a blower orflow generator.

A range of mask systems are known including nasal masks, nose & mouthmasks, full face masks and nasal prongs, pillows, nozzles & cannulae.Masks typically cover more of the face than nasal prongs, pillows,nozzles and cannulae. Nasal prongs, nasal pillows, nozzles and cannulaeall will be collectively referred to as nasal prongs.

There is a continuous need in the art to provide mask systems with ahigh level of comfort and usability.

SUMMARY OF THE INVENTION

One aspect of the invention relates to a patient interface including asealing arrangement adapted to provide an effective seal with thepatient's nose, an inlet conduit arrangement adapted to deliverbreathable gas to the sealing arrangement, and a cover thatsubstantially encloses the sealing arrangement and/or the inlet conduitarrangement.

The cover and/or the sealing arrangement may include one or moreportions constructed of a textile and/or foam material. The sealingarrangement may have a laminated or multi-layer construction. Thesealing arrangement may seal under, around, and/or slightly within thepatient's nose. The sealing arrangement may take the form of a nasalcradle, nasal cushion, or nasal prongs. The sealing arrangement mayinclude a “leaky” seal to allow breathing, avoid moisture, and/or allowgas washout.

The cover and/or inlet conduit arrangement, and in particular thesurface that engages the patient's face/head, can be modeled from across-section of a elliptically shaped conic member. The cross-sectionmay have a width that defines a tapered surface adapted to engage thepatient's head. The tapered surface converges in a direction forward ofthe patient's face.

The cover may incorporate one or more regions having different colors(color contrast), patterns, and/or surface texture, e.g., a two-tonecolor scheme.

In an embodiment, the patient interface may provide minimal adjustment,e.g., one or no adjustment points.

The cover and/or inlet conduit arrangement may have a contour thatblends or forms an organic extension of the patient's face/head, e.g.,non-circular or tapered.

The inlet conduit arrangement may integrally include the cover or thecover may integrally include the inlet conduit arrangement.

Another aspect of the invention relates to a method for fitting apatient interface to a patient including locating a sealing portion ofthe patient interface with respect the patient's nose and/or mouth, androtating or pivoting the patient interface about the sealing portiononto the patient's head until the patient interface self locates ontothe patient's head. The method may include additional adjustment, e.g.,adjustment of a rear strap, to further secure the patient interface ontothe patient's head.

Other aspects, features, and advantages of this invention will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thisinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this invention. In such drawings:

FIGS. 1-1 to 1-7 are various views of a patient interface according toan embodiment of the present invention;

FIGS. 2-1 to 2-19 illustrate various embodiments of textile sealsaccording to embodiments of the present invention;

FIGS. 3-1 to 3-3 illustrate exemplary cross-sections through a cover ofa patient interface according to embodiments of the present invention;

FIGS. 4-1 to 4-2 are various views illustrating a patient interfaceshape according to an embodiment of the present invention;

FIGS. 4-3 to 4-5 are various views illustrating patient interface fit toa patient according to an embodiment of the present invention;

FIGS. 5-1 to 5-2, 6-1 to 6-2, 7-1, 8-1 to 8-2, and 9-1 to 9-3 illustratepatient interfaces including nasal cradles according to embodiments ofthe present invention;

FIGS. 10-1, 11-1, and 12-1 to 12-2 illustrate patient interfacesincluding nasal cushions according to embodiments of the presentinvention;

FIGS. 13-1 to 13-2 and 14-1 to 14-2 illustrate patient interfacesincluding nasal prongs according to embodiments of the presentinvention;

FIGS. 15-1 to 15-2 illustrate a flexible shell according to anembodiment of the present invention;

FIGS. 16-1 to 16-23 illustrate patient interfaces including one or moreoptions to enhance and/or facilitate the treatment session according toembodiments of the present invention; and

FIGS. 17A to 41B illustrate other exemplary lifestyle options or patientinterfaces to enhance and/or facilitate the treatment session accordingto embodiments of the present invention.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

The following description is provided in relation to several embodimentswhich may share common characteristics and features. It is to beunderstood that one or more features of any one embodiment may becombinable with one or more features of the other embodiments. Inaddition, any single feature or combination of features in any of theembodiments may constitute additional embodiments.

While patient interfaces are described as including nasal cradles, nasalcushions, or nasal prongs of the type described below, the patientinterfaces may be adapted for use with other suitable breathingarrangements. That is, the breathing arrangements are merely exemplary,and aspects of the present invention may be applicable to otherbreathing arrangements, e.g., full-face masks, mouth masks, etc.

Embodiments of the invention are directed towards moving fromuncomfortable, unattractive mask systems to sleek patient interfacesthat are soft, comfortable, lightweight, functional, therapy enhancing,fashionable, easy to fit and adjust with little or no adjustment, shapeholding, low impact, low profile, individualized or customized, and/orare more appealing and much less objectionable by patients and bedpartners alike. The subject patient interfaces are less obstructive andseem to be an organic extension of and/or blends with the patient,rather than a bulky, mechanical extension affixed to the patient whichcan appear to be ungainly or unattractive. This can help the patient andthe patient's bed partner more readily sleep during treatment. Moreover,the patient interface can improve the overall perception such that thepatient is simply wearing a garment like a night cap or bed clothes,etc. rather than being treated for a respiratory illness. This improvedperception can help increase the chances that the patient will actuallywear the patient interface and better comply with therapy, whichincreases the chances that the therapy will be effective. There is alsothe possibility that the bed partner will more readily participate inthe patient's therapy by encouraging use of an easy to use/adjust, moreattractive and/or appealing interface.

1. First Illustrated Embodiment of Patient Interface

FIGS. 1-1 to 1-7 illustrate a patient interface 10 according to anembodiment of the present invention. As illustrated, the patientinterface 10 includes a sealing arrangement 20 adapted to provide aneffective seal with the patient's nose, an inlet conduit arrangement 30(FIGS. 1-2) adapted to deliver breathable gas to the sealing arrangement20, and a cover 40 (also referred to as a sock or covering) thatsubstantially encloses the sealing arrangement 20 and optionally theinlet conduit arrangement 30. Specifically, the cover 40 is structuredto expose a sealing portion 22 of the sealing arrangement 20 adapted toform a seal with the patient's nose and optionally a connector ormanifold 32 (FIG. 2) of the inlet conduit arrangement 30 adapted toconnect to an air delivery tube 5. The cover 40, as well as internaltubing, etc., helps to provide the patient interface 10 with aself-holding form so that the patient interface 10 can retain its shapewhether on or off the patient's head (e.g., see FIGS. 1-5 and 1-6). Thecover 40 could also be structured to cover only a smaller portion of thepatient interface.

In embodiments, the cover 40 and the sealing portion 22 are constructedof a textile (e.g., woven or non-woven textile) and/or foam material.This arrangement provides a “total soft” configuration adapted tointimately engage the patient's face. In addition, the “total soft”configuration is visually appealing and stylistic to help remove thestigma of wearing of a mask.

1.1 Sealing Arrangement

In the illustrated embodiment, the sealing arrangement 20 is in the formof a nasal cradle having the sealing portion 22 that provides aneffective seal under the patient's nose in use. The sealing portion 22may be supported by a support or frame that is enclosed within the cover40, e.g., such as the rigid shell shown in FIG. 2-10.

The sealing portion 22 is constructed of a porous material, e.g.,textile or foam, such that the sealing portion 22 provides a breathableseal or a “leaky” seal with intentional/controllable leak. In anembodiment, the material of the sealing portion may be selected tomanage moisture, e.g., avoid moisture in some regions and encouragemoisture in other regions, e.g., near nose for humidification.Hydropholic and hydroplylic materials (or treatments resulting insimilar properties) are some options.

The sealing portion 22 may have other suitable configurations, e.g.,nasal cushion, nasal prongs, etc.

1.1.1 Foam Seal

In an embodiment, the sealing portion 22 is formed with foam andprovides a foam seal or interface under the patient's nose in use (notup the nose). Due to foam's construction, the foam seal provides abreathable seal such that condensation buildup and associated irritationcan be avoided at the contact interface between the patient and sealingportion. The foam provides “a leaky” seal with intentional/controllableleak through the foam structure/matrix that helps to create aircirculation to keep the contact surfaces relatively dry and comfortable.The foam seal is constructed to leak within predictable andpredetermined limits. In an embodiment, the foam vent provides thenecessary volume of CO₂ washout, which may obviate the need for separateCO₂ washout vents. However, CO₂ vent holes may be used in conjunctionwith the foam seal.

The foam seal provides an “unskinned” arrangement that does not grip orstick to the patient's skin, does not stretch or need to stretch, andprovides controllable leak. Thus, the foam seal minimizes skin breakdownand contaminants. In addition, the foam seal is breathable to keep thepatient's face relatively dry in use.

The foam seal provides a warming sensation to the patient's nares uponexhalation, e.g., similar to breathing into a blanket on a cold night.This arrangement reduces the “frozen nose” effect experienced by someusers of nasal prong interfaces. In an embodiment, the foam seal mayinclude extended side portions that extend along sides of the patient'sface, e.g., along upper cheek regions between the air delivery conduitsand the patient's cheeks near or extending from the mouth, to providethe warming sensation to other areas of the patient's face. In anexemplary embodiment, the extended side portions may connect with theconnector.

The foam seal provides an extremely soft (but reinforced) viscoelasticfoam interface with the patient. The foam seal provides ultimate comfortand unobtrusiveness due to its highly unobtrusive design, e.g., similarto nasal prong interfaces. However, unlike nasal prong interfaces, thefoam seal does not include the intrusive feeling of prongs sticking upthe patient's nose. In addition, the foam seal eliminates the jettingeffect of nasal prong interfaces, since the foam helps to diffuse thegas.

Also, the foam seal provides ultimate compliance as the region ofsealing is less complex and has less anthropometric variation comparedto conventional nasal and full face interfaces. The foam can deform tothe appropriate size and shape without compromising the seal and withoutadding discomfort to the patient. In addition, the highly compliant foamfits and seals a broader range of population variation for a given size(e.g., especially compared to silicone interfaces). Further, the foamseal is more compliant because it is less reliant on strap tension fromheadgear.

1.1.1.1 Foam Seal Properties

The foam seal may have a closed cell or open cell arrangement. Also, thefoam seal may provide gradual opening in use. In embodiments, the foamseal may have selected volume and surface properties.

Other advantages of the foam seal include ease of formation, relativelycheap material and tooling costs, and lightweight.

1.1.2 Textile Seal

In an alternative embodiment, the sealing portion 22 may be constructedof a textile material to provide a textile seal or interface under thepatient's nose in use. The textile seal also provides a breathable sealor a leaking seal with intentional/controllable leak.

1.1.2.1 Single Layer Textile Seal On Flexible Support

As shown in FIGS. 2-1 to 2-3, the sealing arrangement may include acylindrical support or base 50, e.g., constructed of silicone, and atextile seal 52 provided to the cylindrical support 50, e.g., attachedwith RTV silicone. The cylindrical support 50 may be attached to a frameadapted to connect to inlet conduits of the inlet conduit arrangement30. The cylindrical support 50 may have a substantially similarstructure to the base portion of a nozzle assembly (with the nozzlesremoved and only the divider 50.1 (FIG. 2-2) therebetween remaining) asdisclosed in U.S. patent application Ser. No. 10/781,929, the entiretyof which is incorporated herein by reference. The flexibility of thecylindrical support 50 adds compliance to the seal. The support may havea split base to be connected with a channel in a frame member preferablywithin the cover or sock. However, the support can be a tube with anaperture and seal around at least a portion of the aperture. In anembodiment, the foam seal may be provided with a support such ascylindrical support 50.

As illustrated, the textile seal 52 includes a single layer of textilematerial, e.g., polar fleece. An opening is provided in the middle ofthe textile seal 52 to allow air flow. As noted above with respect tothe foam seal, the textile seal 52 may provide a warming sensationaround the nose upon exhalation.

1.1.2.2 Multi Layer Textile Seal On Flexible Support

As shown in FIGS. 2-4 to 2-6, the sealing arrangement may include acylindrical support or base 250, e.g., constructed of silicone, and amulti layer textile seal 252 provided to the cylindrical support 250.

As illustrated, the textile seal 252 includes multiple layers, e.g., 2,3, or 4 layers (four layers in this example), of textile material, e.g.,polar fleece, attached to one another. An opening is provided in themiddle of the textile seal 252 to allow air flow. In an embodiment, someof the textile may be carved away around where the tip of the patient'snose would rest, e.g., to relieve some of the pressure.

1.1.2.3 Textile Seal On Rigid Support

As shown in FIGS. 2-7 to 2-10, the sealing arrangement may include arigid shell 350 and a textile seal 352, e.g., polar fleece, provided tothe rigid shell 350. The rigid shell 350 provides the textile seal witha rigid mounting surface to rest on. The compliance in the textile isutilized to create a seal in use.

In an embodiment, foam, e.g., EVA foam, may be provided between therigid shell 350 and the textile seal 352.

Also, the rigid shell 350 includes tubes 351 that are adapted to engagea respective inlet conduit, elbow, cap, and/or headgear. As illustrated,the cut out area in the frame for the patient's nose is deeper then thatfor the patient's upper lip.

FIGS. 2-11 to 2-13 illustrate another embodiment of a sealingarrangement including a rigid shell 450 and a textile seal 452, e.g.,polar fleece, provided to the rigid shell 450, e.g., glued using RTVsilicone. In this embodiment, the rigid shell 450, e.g., formed ofPerspex sheeting, is provided to a tube 453, e.g., polyolefin tube.

1.1.2.4 Textile Seal On Hinged Shell

As shown in FIGS. 2-14 to 2-16, the sealing arrangement may include asemi-rigid or hinged and/or bendable shell 550, e.g., formed ofsilicone, and a textile seal 552, e.g., polar fleece, provided to thesemi-rigid or hinged shell 550.

The shell 550 may have any suitable cross-section, e.g., D-shaped, andincludes a central rib 551 for rigidity. A hinge point, e.g., openingcovered by flat silicone sheet, is provided on each side of the centralrib 551 that allows the shell 550 to hinge or bend about two points (seeFIG. 2-16). The hinged shell may facilitate sealing around the sides ofthe patient's nose as the hinged shell allows the textile seal to atleast partially wrap around the nose. Other exemplary hinged and/orbendable shells are disclosed in U.S. patent application Ser. No.10/533,928, the entirety of which is incorporated herein by reference.

1.1.2.5 Textile Seal On Cylindrical Shell

FIGS. 2-17 to 2-19 illustrate a sealing arrangement including acylindrical shell 650 and a textile seal 652, e.g., silicone coatedtextile, provided to the cylindrical shell 650. The textile seal 652 maybe wrapped around the shell 650, and the orifice 654 in the textile seal652 is aligned with a cut-out 650.1 in the shell 650. As illustrated,the orifice 654 in the textile seal 652 is generally triangular (withconcave sides) and may be provided in different sizes, e.g., L (large),MW (medium wide), and MN (medium narrow) as shown in FIG. 2-18. Thetextile seal may be mounted on a substrate to allow quick fastening andremoval to the shell, for example, hook and loop fastener, or thesubstrate may be in the form of a C-shaped semi-rigid member that canflex to fit over the shell.

In an alternative embodiment, an overlapping textile seal may be improvefit and stability. The overlapping textile seal may be formed bystacking different orifice sizes. The outside layer may include a largehole, and subsequent layers would get smaller. There may be a gapbetween each layer. In use, the patient's nose may slide into the sealand stop when a seal is achieved, e.g., like dropping a ball into afunnel.

Also, elastic elements may be added to the tips of the triangle-shapedorifice to aid in sealing and fit range. A larger orifice could be used,and the elastic elements would pull the points together helping inrestricting leak.

In addition, the shell may be structured to allow more clearance for thepatient's nose. For example, the shell may include a curve adapted tosubstantially clear the tip of the patient's nose.

1.2 Inlet Conduit Arrangement

The inlet conduit arrangement 30 is communicated with the sealingarrangement 20 to deliver breathable gas to the sealing arrangement 20.In the illustrated embodiment, the inlet conduit arrangement 20 includesone or more inlet conduits and a connector coupled to the inletconduit(s). In one embodiment, a single inlet conduit can communicatebetween the inlet conduit and the sealing arrangement. However, it ispreferred that two inlet conduits be used, so that the size of eachconduit can be reduced and provide less obtrusiveness to the patient.

1.2.1 Inlet Conduits

Each inlet conduit includes a first end adapted to engage a respectiveend of the frame that supports the sealing portion 22. For example, theframe may be structured like the frame shown in FIG. 2-10, and the inletconduits are adapted to engage respective tubes provided on opposingends of the frame, e.g., via friction fit. In use, the inlet conduitsare supplied with pressurized breathable gas, and the pressurizedbreathable gas is delivered into opposing ends of the sealingarrangement 20.

1.2.1.1 Inlet Conduit Cross-Section

The inlet conduits (and hence tubes on the frame) may have any suitablecross-sectional shape, e.g., cylindrical, elliptical, flatter section,etc. The cross-sectional shape of the inlet conduits at least partiallydetermines the shape of the cover that encloses the inlet conduits. Inthe illustrated embodiment, the inlet conduits have a non-cylindricalcross-sectional shape which provides a blending contour to blend withthe patient's face, as described in greater detail below. The conduitsmay have a flat configuration with anti-crush ribs such as tubesdisclosed in U.S. patent Ser. No. 10/385,701, the entirety of which isincorporated herein by reference.

1.2.2 Connector/Manifold

As best shown in FIGS. 1-6 and 1-7, a connector or manifold 32 isprovided to interconnect the inlet conduits and provide continual flowfrom the air delivery tube 5 to the inlet conduits. As illustrated, theconnector 32 is generally T-shaped and includes a base portion 34 and aninlet tube portion 36 that is movably coupled (e.g., via a ball joint,hinge, general flexibility, etc.) to the base portion 34.

The base portion 34 includes a first tube 35 a to engage one inletconduit, e.g., via friction fit, and a second tube 35 b to engage theother inlet conduit, e.g., via friction fit. The cross-sectional shapeof the first and second tubes 35 a, 35 b may be non-circular andcorresponds to the cross-sectional shape of the inlet conduits. The baseportion 34 may be curved to match the shape of the patient's head and isotherwise suitably contoured such that it can rest and sit substantiallyflush with the top of the patient's head in use. In addition, the baseportion 34 has a low profile which provides a low moment in use. Asshown in FIGS. 1-1 to 1-6, the base portion 34 is substantially coveredby the cover 40 to provide an integrated look.

As shown in FIG. 1-6, the inlet tube portion is angled towards the rearof the head. The inlet tube portion can be fixed, or the inlet tubeportion 36 can be movable coupled, e.g., swivel, to the base portion 34so that the inlet tube portion 36 can be angled with respect to the baseportion 34 in use. The inlet tube portion 36 has an inlet tube 37, e.g.,15 mm diameter, adapted to connect to an air delivery tube connected toa flow generator. The inlet tube 37 is relatively long to facilitateconnection with the air delivery tube. Also, base 38 of the inlet tubeportion 36 has an exterior curvature continuous with the base portion34.

In an embodiment, the connector 32 may be flocked (e.g., lots of littlebits of yarn or fluff adhered to it). Alternatively, a textile wrap-overmay be provided to the connector 32 to achieve a smooth surface. Thebase portion 34 and/or inlet tube portion 36 may incorporate one or morestops to limit rotation of the inlet tube portion 36 in use.

In an alternative embodiment, the connector 32 and inlet conduits may beintegrally formed as a one-piece structure, e.g., to reduce the numberof parts.

1.2.3 Offset Attachment

In the illustrated embodiment, the connector 32 is positioned at the topof the patient's head. In alternative embodiments, the connector 32 maybe offset from the top of the patient's head, e.g., positioned at a sideof the patient's head. This offset arrangement may provide more comfortas there may be less drag.

The length of the inlet conduits may be selected to adjust the connectorto a position where the patient can view and more easily manipulate airdelivery tube connections.

In an embodiment, the connector 32 may have an adjustable connection,e.g., sliding coupling, so that two or more positions of the connector32 may be selected.

1.3 Cover

As shown in FIGS. 1-1 to 1-6, the cover 40 substantially encloses theinlet conduits of the inlet conduit arrangement 30 and the frame of thesealing arrangement 20, thereby only exposing the sealing portion 22that forms a seal and the inlet tube 37 that connects to the airdelivery tube. The covered patient interface appears more like clothingand provides an organic form which is more appealing as described inmore detail below.

As illustrated, the cover 40 includes a lower portion 42 that covers theframe of the sealing arrangement 20, side portions 44 that cover theinlet conduits and the base portion 34 of the connector 32, and a rearportion 46 that extends across the side portions 44. The lower portion42 provides an opening to expose the sealing portion 22 and the sideportions 44 provide an opening to expose the inlet tube 37.

The cover 40 holds the sealing arrangement 20 and the inlet conduitarrangement 30 such that the side portions 44 guide the inlet conduitsfrom the sealing arrangement 20 along the sides of the patient's head,over the patient's ears, and to the top of the patient's head. The sideportions 44 hold the connector 32 at the top of the patient's head forconnection to the air delivery tube. The rear portion 46 extends acrossthe rear of the patient's head.

The rear portions 46 may be in the form of an adjustable strap that isselectively adjustable to adjust its length. For example, the rear strap46 may include an adjuster 48 similar to a baseball cap (see FIG. 1-4).This arrangement provides a good fit range with minimal sizes. However,other suitable adjustment mechanisms are possible, e.g., hook and loopmaterial, ladder lock, elastic, etc.

The cover 40 helps to maintain the sealing arrangement 20 and the inletconduit arrangement 30 in a desired position. That is, the cover 40includes structural integrity or a self-holding form so it holds thepatient interface's shape, e.g., shape memory, whether the patientinterface is on or off the patient's head. In addition, the cover isformed of a material, e.g., textile or foam, that provides intimate andcomfortable contact with the patient's face. The cover provides awarming effect, i.e., non-clinical feeling like an article of clothingrather than medical equipment.

1.3.1 Cover Material

The cover 40 may be constructed of a textile material (woven ornon-woven textile), e.g., fleece, fabric material. Exemplary materialsinclude Polar Fleece Materials and in particular their “Power Stretch”Material. The textile material is preferably soft in appearance andtouch, and relatively easy to incorporate colors. Also, non-woventextile may be moldable, e.g., Novolon.

In an embodiment, the cover 40 is constructed of material that isnon-reflective or has low reflectivity. Non or low reflectivity is acharacteristic that could be used to broadly distinguish textile coveredpatient interfaces from plastic masks. Also, non or low reflectivity isadvantageous in terms of not reflecting too much light.

In an alternative embodiment, the cover may be constructed of a foam,cardboard, or paper material.

In another alternative embodiment, the patient interface, the airdelivery conduit, and/or the flow generator may have a similar surfacematerial which may provide continuity in surface finish.

1.3.2 Cover Color and/or Pattern

The cover 40 may incorporate one or more regions having different colors(color contrast), patterns, and/or surface texture. In the illustratedembodiment, the cover includes a two-tone color scheme, e.g., a darkcolor D and a light color L. As illustrated, the dark color D ispositioned adjacent the field of vision. This arrangement provides a lowimpact, sleek look.

The two-tone textile cover 40 slims the perception of the size of thepatient interface 10 on the patient's face. That is, this arrangementhas the functional advantage that lighter colors, e.g., white, can beincorporated into the cover 40 that make the relevant region looksmaller, slimmer, or less bulky. Thus, the patient interface 10 has alower visual impact (e.g., less aesthetically obtrusive). In addition,the patient interface may be more fashionable like clothing. Inalternative embodiments, one or more light colored lines, e.g., whitelines, may be incorporated into the cover 40.

Different colors, patterns, and/or surface texture may be selected fordifferent users. In an embodiment, the cover 40 may be transparent orselected to blend in with the patient's skin, e.g., camouflaged or skincolor. For example, if the patient has relatively darker skin, the cover40 could be black or dark brown to blend with the patient's skin. In analternative embodiment, the color and/or texture of the cover 40 may beselected to match the patient's hair.

1.3.3 Removable Cover

In an embodiment, the cover 40 may be removable from the sealingarrangement 20 and the inlet conduit arrangement 30 for cleaning and/orreplacement. The cover 40 may incorporate a zipper and/or Velcro®, forexample, to facilitate removal/attachment. This arrangement allowsdifferent colored, patterned, and/or textured covers to be interchangedfor aesthetics or replacement.

1.3.4 Machine Washable

The material of the cover 40 may be selected such that the cover 40 canbe washable, e.g., machine washable. For example, the cover 40 may bewashed when removed from the sealing arrangement 20 and the inletconduit arrangement 30. In an embodiment, the entire patient interface10 may be constructed such that the entire assembly may be washable,e.g., machine washable.

1.3.5 Organic Form of Cover

In the illustrated embodiment, the cover 40 provides a blending contouror free form with no sharp edges or straight lines. The blending contouris smooth and blends or tapers the cover 40 with or into the contours ofthe patient's head, e.g., less obtrusive. In addition, the blendingcontour has no sharp edges that could cause skin irritations orabrasions.

The contour of the cover 40 may vary non-uniformly with location aroundthe patient's head. For example, the cover 40 may provide flatterregions in certain areas, e.g., where the patient rests on the coverduring sleep. In this way, the cover can be said to be an organicextension of the patient's facial contours.

FIG. 3-1 illustrates an exemplary cross-section of the cover 40. Asillustrated, the cover 40 provides an internal surface 60, an externalsurface 62, and an interior form 64 defined between the internal andexternal surfaces 60, 62.

The internal surface 60 is adapted to sit substantially flush againstthe patient's face in use. As described in greater details below, theinternal surface 60 has a tapered configuration form an inner edge to anouter edge to provide a comfortable fit for a wide range of patients.The internal surface 60 provides a relatively large surface area whichresults in a more even load distribution. This arrangement is lesslikely to create pressure points in use. Also, the internal surface 60may have grip-like material to help stabilize the patient interface onthe patient's face.

The external surface 62 has a smooth contour that blends with thepatient's face. That is, the external surface 62 has a profile ororganic form with edges that blend into the patient's face, e.g., in atangential manner, to prevent any edges from catching on bedclothes,pillows, etc., during sleep (e.g., when the patient rolls over).

The interior form 64 of the cover is determined at least in part by thesealing arrangement 20 and/or the inlet conduit arrangement 30 extendingtherethrough. For example, FIG. 3-1 illustrates a side portion 44 of thecover in which the inlet conduit 31 extends therethrough. Asillustrated, the inlet conduit 31 has a generally elliptical shape andthe interior form 64 of the cover encloses the inlet conduit 31.

The cross-section of the cover may vary along its length, e.g., bychanging the cross-section of the inlet tube and/or the interior form64.

FIGS. 3-2 and 3-3 illustrate alternative cross-sections of the cover. Asshown in FIG. 3-2, the cover may provide a gap 66 in the internalsurface 60, e.g., to allow air flow or breathing of the cover. As shownin FIG. 3-3, the cover may have a D-shaped cross-section. While lesspreferred than the cross-sections shown in FIGS. 3-1 and 3-2, thecross-section of FIG. 3-3 would be more preferable than a normalcylindrical conduit for its blending contour. However, othercross-sectional shapes are possible, e.g., oval.

In embodiments, the overall cross-sections in FIGS. 3-1 to 3-3 mayrepresent the shape of the inlet conduit per se, and the cover is simplyformed to cover, preferably in a conforming way, the shape of the inletconduit. In an alternative embodiment, the “cover” could just beprovided on the inside surface of the inlet conduit, i.e., the side incontact with the patient's face.

1.4 Auto-Adjustment

The patient interface 10 is structured such that little or no adjustmentis needed to fit the patient interface 10 to the patient's head. Thus,the patient interface 10 is relatively self-locating. For example, theinlet conduits and/or the side portions 44 of the cover 40 extendingfrom the sealing assembly 20 to the crown of the patient's head at leastin part define a generally truncated elliptical cone or funnel, thusforming a tube-cover ring. FIG. 4-1 illustrates a an oval-shaped conethat can be used as a template for designing purposes. The cone tapersfrom a smaller ellipse to a larger ellipse along axis A. Thecross-section is selected along axis A to fit the largest possiblepopulation, given that the shape will be generally fixed. The shadedregion 44′ on the conical shape in FIG. 4-1 substantially represents anembodiment of the internal surfaces of the conduits and/or cover, inparticular hoop-shaped side portions 44 of the patient interface. Asshown in FIG. 4-2, the internal surfaces define an inner elliptical edgeI that tapers to an outer elliptical edge O. A tapering surface orconical-elliptical ring is provided between the inner and outer edges todefine a contact surface that engages the patient. The outer ellipticaledge O has larger major and minor axes D₁, D₂, than the major and minoraxes d₁, d₂ of the inner elliptical edge I. The width of the internalsurfaces may vary.

At least a portion of the internal surfaces of the cover are adapted toengage the patient's head in use, and the tapered or angledconfiguration of the internal surfaces allows the patient interface tofit a variety of differently shaped heads.

Specifically, the cover is oriented such that the larger edge O facesinwardly towards the patient. As the patient interface is fitted to thepatient's head, the patient's head will extend through the larger edge Otowards the smaller edge I. Depending on the size of the patient's head,the tapered internal surfaces will engage the patient's head indifferent positions. For example, if the patient has a larger head,patient interface may sit higher up on the patient's head. If thepatient has a smaller head, the patient interface may sit more towards arear portion of the patient's head. Once fit, the patient may adjust therear portion 46 as necessary. Thus, the patient may require a singleadjustment to fit the patient interface to his/her head.

In alternative embodiments, the internal surfaces may taper along one orselected portions. Also, the internal surfaces may symmetric orasymmetric, e.g., side portions may have a bend. This may be designedusing FIG. 4-1, e.g., by angling the upper portion of the cross-sectioneither forwards 44.1 or rearwards 44.2 along the axis A, depending onwhere the top portion of the conduit/cover is intended to contact thepatient.

1.4.1 Method to Fit Patient

FIGS. 4-3 to 4-5 illustrate an exemplary method for fitting the patientinterface to a patient. As shown in FIG. 4-3, the sealing arrangement 20may first be located under the patient's nose. Then, as shown in FIG.4-4, the cover and inlet conduit arrangement enclosed therewithin may berotated about the sealing arrangement onto the patient's head. Thepatient interface is rotated, e.g., for X°, until the tapered sideportions 44 engage the patient's head and prevent further movement.Finally, as shown in FIG. 4-5, the rear portion 46 of the cover may beadjusted as necessary to secure the patient interface on the patient'shead.

1.4.2 Sizing

In the illustrated embodiment, the patient interface 10 includes asingle adjustment point, e.g., adjustable rear portion 46. In anembodiment, the rear portion 46 may be tailored or modified to fit thepatient at the point of sale, and then altered to prevent furtheradjustment, e.g., tear off.

In an alternative embodiment, the patient interface 10 may have anon-adjustable slip-on shape, e.g., like a shoe, with little or noelasticity. In this arrangement, the patient interface 10 may beprovided in many different sizes, e.g., up to 20 different sizes, 5, 10,15, or any other number of sizes. This arrangement is aided bycompliance of the seal.

1.5 Expandable Cover

In an embodiment, the inlet conduits may be provided by the cover 40itself. That is, the side portions 44 of the cover 40 may be structuredto form conduits that deliver air from the connector 32 to the sealingarrangement 20. For example, the cover may be generally elastic untilpressure is applied, and then expand and become inelastic upon theapplication of pressure. Such an alternative embodiment is discussedbelow. Also, inflatable conduit headgear is disclosed in PCT applicationno. PCT/AU05/00539, the entirety of which is incorporated herein byreference.

1.6 Foam Patient Interface

In an alternative embodiment, the entire patient interface may beconstructed from foam. In this arrangement, the foam patient interfacemay be pre-formed to provide a custom fit with the patient.

1.7 Advantages, Features, and Options

The patient interfaces described above and below are structured toimprove patient quality of life by improving their quality of sleep.This is achieved by developing a patient interface with an unobtrusive,friendly look and feel (e.g., eliminating self-consciousness and“medical” perception and associated negative connotations), enhancedusability (e.g., simple and intuitive to fit and maintain), and enhancedcomfort.

The patient interfaces described above and below may each include one ormore of the following advantages, features, and options. In addition,any single advantage, feature or option may constitute additionalindependent embodiments of the present invention.

Organic;

Non medical—treated as clothing;

Soft, not “hard”;

Subtle—looks simple but stylistic;

Sleek and sophisticated;

Simple to put on and take off;

Accurate 1^(st) time fit;

Intuitive;

Allows total freedom of movement;

Easy cleaning/maintenance;

Limited (no) pressure points;

“Silent” and no jetting—minimal disturbance to patient and partner;

Minimal headgear intrusion;

Easy and comfortable to breathe on;

Intimate or personal—physiologically and aesthetically “fit”/look“right” on the wearer;

Worn akin to clothing;

Removes stigma (shame) of wearing a CPAP patient interface;

High perceived value;

Sleep enhancing features, e.g., optimize stimuli for all five senses(Sight—optional eye covering, Hearing—white noise, music, noisecancellation, ear muffs, Taste and Smell—scents, Touch—heating/cooling,no pressure points;

Provides patient total freedom of sleeping position (e.g., sleep inprone position);

Fashionable—proud to own and display;

Washable in a washing machine or dishwasher;

No or little adjustment required (e.g., socks);

Improved portability;

Simpler with less parts;

Patient compliance;

Rolled or foldable into compact travel size;

Low profile;

Replaceable seal area, e.g., disposable; and

Overmolded components.

The following patents and applications may include options or featuresthat may be incorporated into one or more of the patient interfacesdescribed above and below. Each of the following patents andapplications is incorporated herein by reference in its entirety.

Position sensitive illuminator disclosed in PCT application no.PCT/AU05/00704;

Mesh Vent disclosed in U.S. Pat. No. 6,823,865;

Variable mesh vent disclosed in PCT application no. PCT/AU05/01941;

Nasal Dilator disclosed in PCT application no. PCT/AU2006/000321; and

Magnetic Headgear Clips disclosed in U.S. application Ser. No.11/080,446.

2. Material Requirements By Functional Area

The patient interface may be divided into functional areas (e.g.,sealing, support, etc.) as opposed to components. Each functional areamay be best implemented using a material selected to perform the desiredfunction. In one embodiment, a single material can meet all functionalrequirements in all functional areas.

2.1 Properties

The following properties may apply to all materials in all functionalareas:

All materials may be suitable for single patient multi use; and

All materials may be able to be bonded with other materials (in a waythat will pass Bio Compatibility and Cytotoxicity requirements).

2.2 Sealing

The sealing region is the area of the patient interface that joins theshell or support of the patient interface to the patient's skin,specifically in and/or around the nose. This connection creates a volumeof pressurized air that the patient is able to breath.

2.2.1 Properties

The following properties may apply to the material in the sealingregion:

Material may have skin-contact and wet-air-path biocompatibilitycompliance;

Material may be appropriate for single patient multi use;

Material may be flexible enough to conform to the skin under pressure;

Material may have a quantifiable leak (if not zero leak between seal andskin, it may be a repeatable known amount);

Material may not hold moisture against the skin, e.g., by wicking;

Material may be non-abrasive to the skin on when moved across the skin(to prevent the outer layer of the skin being removed);

Material may be durable and cleanable; and

Material may be appropriate for multi patient multi use.

2.2.2 Solutions

The following materials may be possible solutions for sealing. For eachmaterial, properties are listed that may make the material work.

2.2.2.1 Flat Textile Seal

The material may have controlled elasticity across the seal section thatuses the patient interface air pressure to create the form and hold theseal against the face. To achieve this, the elasticity may be varyingacross the material, but controlled. The seal may act in a similar wayto known bubble cushions; the frame (shell) may not provide the sealingvectors, but simply translate the sealing force from the headgear to thecushion (seal).

The seal may be a flexible flat piece and the shell provides form to theseal. This flat piece may be cut with the required profile to negotiatethe nose. Since the material is flexible and has no rigid elements, itmay follow the form of the shell, and all sealing vectors may be betweenthe patient and the shell (as apposed to the patient and the seal). Toachieve this, the shell may have elements integrated into it to providethe reaction force for the seal. These rigid elements may be foam,inflexible sections, inflexible inserts, etc.

2.2.2.2 Quilted Sections to form 3D shape

Multiple flat sections may be joined (e.g., by gluing, stitching,welding, etc) to form a three dimensional object. Each flat section mayhave different properties from one another, e.g., elasticity,flexibility, thickness, texture, etc.

2.2.2.3 Three Dimensional Weaving

The seal may be woven using three-dimensional weaving techniques. Thismay allow a three dimensional object to be created from one piece ofmaterial without seams. The material may have varying properties indifferent areas of the seal. This may be possible by using differentthreads/yarns. Properties to be changed may include elasticity,flexibility, texture, thickness (friction, feel, etc), air permeability,etc.

2.3 Gas Venting

The gas venting region is the area of the patient interface that allowsflow to atmosphere with the goal of washing away exhaled air. The flowshould be low enough to create backpressure within the patientinterface, and should not be affected significantly with humidificationor create excessive noise.

2.3.1 Properties

The following properties may apply to the material in the gas ventingregion:

Material may be able to manufactured with batch consistency of vent flow(flow should be the same between manufacturing batches);

Material may be appropriate for single patient multi use;

Material may have wet-air-path biocompatibility compliance;

Material may produce minimal noise when airflow is passed through it;

Material may produce a vent with diffuse jetting;

The flow through the vent may not be reduced by more then 20% byhumidification;

The flow through the vent may return to specification within X minutesafter soaking the material in water;

The vent flow may not change over the lifetime of the product (i.e., itwill not deteriorate with cleaning);

The vent location may take into consideration the possibility ofocclusion due to patient position;

The material may be able to be colored and may be colorfast; and

The material may be flexible.

2.3.2 Solutions

The following materials may be possible solutions for gas venting. Foreach material, properties are listed that may make the material work.

2.3.2.1 Wicking Material

A textile with similar properties to CoolMax may be used as the vent.The material may have the property that moisture evaporates more readilythen it condensates (resulting in no restriction of flow due tocondensation of moisture in the vent). If the material is stretchy, theflow should not be effected when stretched (i.e., gaps between the yarnsmust not change significantly enough to effect the flow).

A textile that is coated with a Gore-Tex membrane may be used as thevent. This would allow moisture to move through the material andevaporate into atmosphere.

A plastic insert may be used to contain a vent. The vent shape may besimilar to our current technology, possibly using multi hole technology.

Holes may be sewn into the shell to be used as vents.

Punching holes into the shell may be possible. These holes should notfray the shell when stretched.

Disposable membrane inserts may be used, e.g., mesh vent.

The shell itself may have a diffuse flow over its entirety henceeliminating the need for a separate venting area.

2.4 Gas Supply

The gas supply connects the breathable volume around the patientinterface to the gas delivery hose.

2.4.1 Properties

The following properties may apply to the material in the gas supply:

The material may not be permeable to air;

The air path (inside) surface may have wet-air-path biocompatibilitycompliance;

The skin contact surface may have skin-contact biocompatibilitycompliance;

The material may be flexible, collapsible and have a soft feel;

The material should form conduit that will be kink-resistant so as tomaintain therapy pressure;

The material may be able to be colored and may be colorfast;

The material may be able to have marketing materialprinted/embossed/embroidered/or other onto it;

The material should not kink or buckle as it bends and conforms to thehead;

The material may have a smooth bore/smooth internal geometry;

The material may be able to be formed to have ribbed internal geometrythat provides kink-resistance;

The material may absorb sound from the air path; and

The material may insulate against the transmission of conduct noise toatmosphere (to prevent patient hearing air rushing through conduit).

2.4.2 Solutions

The following materials may be possible solutions for gas supply. Foreach material, properties are listed that may make the material work.

2.4.2.1 Molded Tube

A silicone, polyethylene or other material may be molded to form anelastic tube that is impermeable to air. If touching the skin, theoutside surface of the tube may have a soft finish.

The molded tube could be laminated with a textile to give it a textileappearance.

A sock may be slipped over the tube.

2.4.2.2 Textile Tube

A textile tube may be created by either a three dimensional weavingtechnique or by using a seam.

The surface of the textile may be laminated with a membrane or othermaterial to control the permeability to air and moisture.

The textile may have a surface treatment applied to it (such as a resin)to control the permeability to air and moisture.

2.4.2.3 Structure for the Tube

Malleable textiles that retain their shape (metallic textiles forexample) may be used (or laminating malleable elements to the tube) toachieve form and provide assistance in achieving the correct sealingvectors. “Solid” sections may be incorporated into the design (such asspacer fabrics) to help provide form. Pockets for solid materials (likeribs in a sail) may be incorporated to allow structural elements to beadded, these materials could come with multiple options to allow forpersonalization of the patient interface. Temporary laminating of rigidelements (like a Velcro system) could also be used to achieve apersonalized fit.

2.5 Anchoring

The anchoring provides stability and location to all other elements ofthe patient interface. The anchoring may be integrated with otherfunctional areas.

2.5.1 Properties

The following properties may apply to the material in the anchoring:

The material may have skin-contact biocompatibility compliance;

The material may be breathable; it may move moisture and heat away fromthe skin (i.e., moisture and air permeable);

The material may have a low profile, e.g., it may be thin;

The material may have the ability to be colored and may be colorfast;

The material may be able to have marketing materialprinted/embossed/embroidered/or other onto it;

The material may have the ability to control direction stiffness,sealing vectors to the shell may be possible;

The material may be elastic; and

The material may be elastic until a normal force is applied (from airpressure in conduit headgear).

2.6 Shell

The shell connects all parts together and provides form to the patientinterface, particularly around the nose to hold the sealing portion inplace.

2.6.1 Properties

The following properties may apply to the material in the shell:

Any surface in contact with breathable air may have wet-air-pathbiocompatibility compliance;

Any surface in contact with the skin may have skin-contactbiocompatibility compliance;

The material may be impermeable to air (or allow a low, diffuse, knownflow through it);

The material may have the ability to be colored and may be colorfast;

The material may be able to have marketing materialprinted/embossed/embroidered/or other onto it;

The material may have the ability to control directional stiffness,force vectors to the seal may be controllable;

The material's outer surface may allow moisture to evaporate. If thematerial's inside surface soaks up moisture, it should be possible forit to escape to the outside surface and then evaporate; and

The material may be permeable to moisture.

2.6.2 Solutions

The following materials may be possible solutions for the shell. Foreach material, properties are listed that may make the material work.

2.6.2.1 Quilted Textile Sections to Form 3D Shape

Multiple flat sections of textiles may be joined (e.g., by gluing,stitching, welding, etc.) to form a three dimensional object. Each flatsection would potentially have different properties from one another,e.g., elasticity, flexibility, thickness, texture, etc. The quilt mayrequire a surface treatment to modify the material's permeability to airand moisture. The quilt may be laminated with other materials to provideform or rigidity (like a foam or adhesive plastic for example).Laminating with membranes may also be used to modify surface propertiesof the quilt such as permeability to air and moisture or even modify thesurface to comply with biocompatibility requirements. Malleable textilesthat retain their shape (metallic textiles for example) may be used (orlaminating malleable elements to the quilt) to achieve form and provideassistance in achieving the correct sealing vectors. “Solid” sectionsmay be incorporated into the design (such as spacer fabrics) to helpprovide form. Pockets for solid materials (like ribs in a sail) may beincorporated to allow structural elements to be added, these materialscould come with multiple options to allow for personalization of thepatient interface. Temporary laminating of rigid elements (like a Velcrosystem) could also be used to achieve a personalized fit.

2.6.2.2 Three-Dimensional Weaving to Form a 3D Shape

A three dimensional weave may be essentially the same as the quiltedtextile method of creating a three dimensional shape. All possiblemethods listed above may be used with a one piece option with theadvantage of having no seams. Possibilities in addition to the oneslisted above may include:

The material may have rigid elements encapsulated by weaving into thematerial;

If any adjacent parts are created using a three-dimensional weavingtechnique, they could be made at the same time and hence there would beno seams between parts. For example, the seal to shell interface wouldno longer exist as they would essentially be the same part.

2.6.2.3 Open Cell Foam Support

Molded self skinning open cell foam may be used.

Molded open cell foam using a textile or other film as the skin may beused. The skin may be put in the mold first, then foam molded into thisskin.

2.6.2.4 Formed Closed Cell Foam

Form may be achieved by thermo forming of vacuum forming sheets of thedesired foam. When forming the foam, wall section thickness variationsmay result in varying density and hence rigidity. For example, if thefoam is pressed thinner in an area, it may have a higher density than anarea with a larger wall section. This may result in a rigid rib thatcould be used to control sealing vectors. The shell and cushion may beformed in one piece, this would result in only one seam. More than oneseam may increase the chance of a poor join and inadvertent leak. Toachieve the required surface properties of the shell, the foam may belaminated with other materials (such as a textile or film) beforeforming.

3. Possible Designs

The following are possible designs for the patient interface.

3.1 Linear Clutch for Easy Adjustment of Conduit Headgear

A self-locking linear clutch may be used in conjunction with thecover/inlet conduits (may be referred to as conduit headgear) to providethe user with a convenient method for adjusting the conduit headgear.The mechanism would be located within the conduit headgear, and woulduse the pressure in the conduit to drive an actuator. The conduit wouldinclude a sleeve and an insert. The insert would be elastic only in theradial direction (i.e., inelastic along its axis), and the sleeve wouldbe inelastic in both radial and axial directions. The insert would beallowed to be moved along its axis in the sleeve, this movement limitingthe amount of fit possible on the patient interface. To prevent theinsert from being completely removed from the sleeve and to provide aseal, the end of the insert would be attached to the inside wall of thesleeve with a very elastic material. In a similar manner, the end of thesleeve would be attached to the outside wall of the insert with a veryelastic material.

In addition to preventing the insert being removed from the sleeve andproviding a seal, the elastic joiners will provide a return force toslide the insert back into the sleeve. The insert will be free to movewhen there is no pressure in the conduit, however, when the flowgenerator is activated and pressure is created in the conduit, theinsert will expand and lock against the sleeve in a similar manner as alinear clutch. This locking action will mean that the headgear can nolonger be extended or reduced.

The above-described mechanism would remove the need for traditionalmethods for adjusting headgear (e.g., buckles, Velcro tabs, etc). Theuser would simply pull the patient interface over their head and theelasticity in the joiners would adjust the headgear to the correctlength. Once the flow generator is activated, the headgear would lockand all adjustment will have been completed.

The contact surfaces of the sleeve and insert may need to have a roughfinish or other elements to increase resistance to ensure that themechanism locks. Other methods of ensuring the clutch locks could be aratchet type lock, pins and holes, etc. The sleeve may also need to beporous (or at least allow air flow) so that the gap between the sleeveand insert has atmospheric pressure (this will create a larger pressuredifferential between the conduit and gap). This may be required toensure that the insert expands.

3.2 Pockets for Insert

Pockets may be made in the shell for inserts. These inserts may be usedto provide structure to the shell, and possibly a custom fit.

3.3 Pull Chord Adjustment of Shell

The fit of the shell may be adjusted by using a pull chord. The chordmay be attached to the end of a semi rigid beam that may bend when thechord is pulled, locking the pulled chord off may force the beam to staybent and hence adjust the form of the shell.

3.4 Skeleton Web

A web made of a flexible inextensible material may be used to create askeleton for the shell. The web may be designed in a way that interactswith the headgear area and may not allow any supporting material to moveaway from the face during treatment. The web may create anchoring pointsfor other shell materials. These anchoring points may provide thereaction forces to create a seal.

3.5 Flexible Shell

As shown in FIGS. 15-1 to 15-2, overlapping rigid elements may be usedto allow flexing in one plane but prevent it in the opposite plane,e.g., similar to technology used in Adidas finger saver goalkeepinggloves. The overlapping elements would be used in the shell to controlflexing, e.g., under the eyes and around the nasal bridge. The elementscould be used in a way that creates a rigid section when attached to theface, but when not on the face the shell can still be rolled up. FIGS.15-1 to 15-2 shows how the system would work. It is noted that thelocation of the hinges provides the constraint on what direction flexingis allowable.

By locating the hinge at the other corner of the rigid element, the flexwill be constrained in the opposite plane to the one illustrated.

4. Alternative Patient Interface Embodiments

The following illustrates patient interfaces according to alternativeembodiments of the present invention. As illustrated, the patientinterface may include a nasal cradle that seals under the nose asdescribed above, a nasal cushion that seals around the nose, or nasalprongs that seal around and/or within the patient's nares.

4.1 Nasal Cradle Embodiments

The following illustrates embodiments of patient interfaces including anasal cradle such as that described above.

4.1.1 First Illustrated Embodiment

FIGS. 5-1 to 5-2 illustrates a patient interface 210 according toanother embodiment of the invention. The patient interface includes asealing arrangement 220 in the form of a nasal cradle, a cover 240, anda T-shaped connector or manifold 232. The patient interface 210 iscompletely soft except for the T-shaped manifold 232.

In an embodiment, the sealing arrangement may include a foam sealingportion provided to a flexible cylindrical support, e.g., such as thesupport shown in FIGS. 2-1 to 2-3. In an embodiment, the support may beformed of a textile.

The cover 240 forms conduits that deliver air from the manifold 232 tothe sealing arrangement 220. The cover 240 may be formed of differentsections that are contoured or curved to match the contours of thepatient's face. The cover 240 is inflatable when pressurized to hold itsform, and becomes flexible when not pressurized, e.g., drapes similar toa piece of clothing when not pressurized. An elastic strap 246, e.g.,lycra, is provided to the cover 240 to secure the patient interface onthe patient's head. The flexible form of the patient interface enhancesdecoupling of headgear forces from sealing forces. The flexible form ofthe patient interface also enhances “cradling” and conformance of thepatient interface to facial contours.

The patient interface 210 provides a good fit range as the anchoring iscompletely disassociated from the conduit. The patient interface 210 isvery comfortable and soft when fitted as the forces are very low. Theconduit length may be adjustable and squeezed onto the manifold. Thepatient interface may be fully reversible, e.g., may be put oncompletely upside down to change tube routing direction.

The following options may be considered in alternative embodiments:

Inserting cuff means that the manifold could be soft non-occludingrubber.

4.1.2 Second Illustrated Embodiment

FIGS. 6-1 to 6-2 illustrate a patient interface 310 according to anotherembodiment of the invention. The patient interface includes a sealingarrangement 320 in the form of a nasal cradle, an inlet conduitarrangement 330, headgear, and a cover 340.

In an embodiment, the patient interface may incorporate one or morecomponents from U.S. patent application Ser. No. 10/781,929, theentirety of which is incorporated herein by reference. For example, theheadgear, inlet conduits, and sealing arrangement in U.S. patentapplication Ser. No. 10/781,929 may be modified to incorporate a nasalcradle, e.g., formed of foam. Then, the modified assembly may be coveredby the cover, e.g., formed of lycra, to provide a softened patientinterface with a good balance of unobtrusiveness, functionality,stability, and intuitiveness of form when off the patient's head.

4.1.3 Third Illustrated Embodiment

FIG. 7-1 illustrates another embodiment of a patient interface 410including a sealing arrangement 420 in the form of a nasal cradle, acover, 440, and inlet conduits defined by or covered by the cover 440.In an embodiment, the inlet conduits may have a D-shaped cross-section,and the cover may be formed of a stretch lycra material. A back strap446 may be provided to secure the patient interface on the patient'shead.

The patient interface 410 maximizes aesthetic look and demonstratesoptimization of sleekness and unobtrusiveness for the intended inletconduit routing. That is, the patient interface 410 provides a smooth,sleek, continuous form under the patient's nose. In an embodiment, thecover may be internally reinforced to maintain form and gently grip thepatient's head.

The following options may be considered in alternative embodiments:

Different conduit sections, with soft lip that conforms to head profile;

Increase width and lower height of conduit as it moves up past the ears;

Incorporate 2 straps at back of head into 1 wider strap;

Hide all steps and edges;

Integrate lower strap to look part of overall form, i.e., add radii andcurves;

Making the lower strap the predominant form by using color change fortop strap;

Continuous amorphous organic form;

Eliminate back strap, grip face better to provide stability;

Non-adjustable conduit ring that fits on any size head, it goes acrossfurther forward on large heads; and

Adjustable conduit section separate from sling that conforms to head.

4.1.4 Fourth Illustrated Embodiment

FIGS. 8-1 to 8-2 illustrate another embodiment of a patient interface510 including a sealing arrangement 520 in the form of a nasal cradle.In this embodiment, substantially the entire patient interface isconstructed of foam, e.g., foam sealing portion 522 and foam cover 540that defines inlet conduits, to provide a softened look and feel. Thepatient interface is ultra lightweight, and may grip the cheeks so as tonot require a back strap.

The texture of the foam looks softer, e.g., compared to shiny materials.Also, the flexibility at front of patient interface allows it to sealwithout any rotational adjustment.

The following options may be considered in alternative embodiments:

Multiple laminates of foam in front of soft foam seal to providestructure and eliminate silicone shell to make it look more flush;

Match sealing foam to shell;

“skullcap” may be provided;

Foam seal extended wider to become a quasi cheek pad and extend thewarming sensation; and

Add branding to provide the instructional cue on which way it goes on toavoid putting on upside down.

4.1.5 Fifth Illustrated Embodiment

FIGS. 9-1 to 9-3 illustrate another embodiment of a patient interface610 including a sealing arrangement 620 in the form of a nasal cradlewith a foam sealing portion 622. In this embodiment, the foam sealingportion 622 is incorporated into an existing nasal assembly such as thatdisclosed in U.S. patent application Ser. No. 10/781,929, the entiretyof which is incorporated herein by reference. For example, the nozzlesmay be removed from the existing assembly, and the remaining baseportion may be modified to incorporate the foam sealing portion 622.FIGS. 9-1 and 9-2 illustrate foam sealing portion 622 on base portion623. The viscoelastic foam interface gently cradles the external naresand provides superior comfort and easy first time seal. Also, the foamseal may require lower headgear tension than the existing nasal assemblywith nozzles, and eliminates jetting effect provided by nozzles.Further, the foam is compliant and exhibits a much larger fit range thansilicone-type interfaces.

4.2 Nasal Cushion Embodiments

The following illustrates embodiments of patient interfaces including anasal cushion.

4.2.1 First Illustrated Embodiment

FIGS. 10-1 illustrates an embodiment of a patient interface 710including a sealing arrangement 720 in the form of a nasal cushion. Inthis embodiment, the entire sealing arrangement is constructed of foam,e.g., foam cushion 724 and foam cushion shell 726. The sealingarrangement 720 is maintained on the patient's head by headgear 780. Inan embodiment, the headgear may also be constructed of foam.

4.2.2 Second Illustrated Embodiment

FIG. 11-1 illustrates another embodiment of a patient interface 810including a sealing arrangement 820 in the form of a nasal cushion. Asillustrated, a cover 840 is provided to enclose the sealing arrangementand inlet conduits to provide an integrated look. In an embodiment, thenasal cushion and shell may be formed of a fabric material. The patientinterface may be adjustable to fit a large range of head sizes, e.g.,rear strap slides along covered conduits.

The following options may be considered in alternative embodiments:

Flattened tube;

Different textile, e.g., terry toweling, materials with deeper pile;

Combine manifold with tube length adjustment mechanism; and

Use tension across sealing areas to change the angle of the patientinterface on the face to accommodate different face shapes.

4.2.3 Third Illustrated Embodiment

FIGS. 12-1 and 12-2 illustrate another embodiment of a patient interface910 including a sealing arrangement 920 in the form of a nasal cushion.In an embodiment, the nasal seal may be formed of silicone and the shelland conduits may be formed of foam. In another embodiment, the nasalseal, shell, and conduits may be formed of foam.

The foam conduits make the patient interface fell like one singleconstruction, e.g., garment like. Also, the foam material folds itsshape, and the texture and/or matte finish of the material looks warmer,e.g., compared to shiny materials. The patient interface provides anintuitive fit and is lightweight. The patient interface material may begrippy or tactile to hold on the patient's skin. In an embodiment, thepatient interface may be formed of one flat dark colour to reduce bulk.Also, the patient interface may be formed of a “Non-medical” color (suchas green) to assist in providing the patient interface with anon-medical look.

The following options may be considered in alternative embodiments:

Externally curving membrane with thin foam support structure holding iton the face;

Width of conduit on front of face no more than about 20 mm;

Joining the conduit to lower down on the shell;

Rubber manifold;

Cover ponytail in textile;

Bend the sides so it extends up to the top of the head;

Forming the shell and seal in one piece;

Embedded wire to form shape;

Add boomerang shape to top lip seal to follow shape of top lip;

Reduce bulk and height of seal;

Lycra/stocking material band to hold seal;

Use stretchy lycra to restrain seal walls from deflecting out bystretching over the nose;

Wrap around headgear attaches with Velcro; and

Glow in the dark portions.

4.3 Nasal Prong Embodiments

The following illustrates embodiments of patient interfaces includingnasal prongs.

4.3.1 First Illustrated Embodiment

FIGS. 13-1 and 13-2 illustrate an embodiment of a patient interface 1010including a sealing arrangement 1020 in the form of nasal prongs. In anembodiment, the patient interface 1010 may be similar to an existingnasal assembly such as that disclosed in U.S. patent application Ser.No. 10/781,929, the entirety of which is incorporated herein byreference. In contrast, the patient interface 1010 includes coverportions or socks 1040, e.g., formed of lycra, to cover inlet conduitsof the patient interface 1010.

In an alternative embodiment, the nasal prongs may be supported by afoam or textile shell.

4.3.2 Second Illustrated Embodiment

FIGS. 14-1 and 14-2 illustrate another embodiment of a patient interface1110 including a sealing arrangement 1120 in the form of nasal prongs.In an embodiment, the patient interface 1110 may be similar to anexisting nasal assembly such as that disclosed in U.S. patentapplication Ser. No. 10/781,929, the entirety of which is incorporatedherein by reference. In contrast, the patient interface 1110 includes acover or sock 1140, e.g., one piece sock formed of lycra, to cover thepatient interface 1110.

The sock 1140 softens the appearance of the existing assembly, and theassembly is more sleek by encapsulating the inlet tube in the “up”position with the sock 1140. That is, the existing assembly looks morearchitectural, smooth, and streamlined, with no edges or seams. Thepatient interface 1110 holds it shape when removed from the patient'shead and has a high quality appearance. The sock 1140 may have one flatdark color to reduce bulk.

Also, the lateral inlet tube position demonstrates excellent tube forcedecoupling. The existing headgear may be modified to incorporate thesock, e.g., removal of headgear tabs on rear strap removed and rearstrap cut and stitched together.

In an alternative embodiment, the nasal prongs may be supported by afoam or textile shell. Also, the inlet tube may have a D-shaped sectionor squashed shape. The sock 1140 may provide adjustment, e.g., baseballcap style adjustment. The sock may have a multi tone/texture/color,e.g., 2 tone, to slim down profile and bulk.

4.4 Advantages and Additional Options

The following are advantages provided by one or more of the embodimentsdescribed above:

No edges, no seams, continuous form, smooth, and streamlined look;

Holding shape when off the patient's head provides a high qualityappearance;

Intuitive fit;

Matte and textured finish of material looks warmer than those with shinyfinish;

Lightweight adds to unobtrusiveness;

Flexibility at front of patient interface allows it to seal without anyrotational adjustment;

Headgear that provides stability by “gripping” to face;

Flatter and more flush conduit (no radii against face) provides moreintimate look;

Anchoring completely disassociated from the conduit improves fit range;and

Reversible concept, patient interface can be put on completely upsidedown to change tube routing direction.

The following options may be considered in alternative embodiments ofone or more of the embodiments described above:

Include branding;

Magnetic connection on the end of the ponytail;

Arc flash—self-disinfecting material treatment that uses light tocatalyze reaction—also silver. Provides functional reason for replacingpatient interface, i.e., indicates end of serviceable life;

Use functionally different materials in different facial locations;

Use different materials to provide seasonal versions, cooler and warmermaterials, possibly phase change for summer;

Hypercolor vent to have color change with breathing—organic and livingand provides an indication to the clinician that all is well and patientis breathing. Also provides an ELSI as life of Hypercolor treatmentreduced with washing; and

Pressure sensitive material to provide indication of pressure level.

5. Lifestyle Options

The patient interface described above may be modified to include one ormore options that enhance and/or facilitate the treatment session. Forexample, the patient interface may include sleep enhancing or lifestyleoptions, e.g., integrated headphones (e.g., with noise cancellation),integrated eye covers, heating/cooling effects, partner version, etc.

Exemplary lifestyle options are disclosed in U.S. patent applicationSer. No. 11/491,016, entitled Lifestyle Flow Generator and Mask Systemand filed Jul. 24, 2006, the entirety of which is incorporated herein byreference.

Other exemplary lifestyle options are shown in FIGS. 16-1 to 16-23.

In each embodiment described below, the inlet conduit arrangement mayinclude tubing, straps, and/or a cover to support the interface on thepatient's head and deliver breathable gas to the sealing arrangement.

For example, FIGS. 16-1 to 16-3 illustrate lifestyle options for afull-face patient interface (e.g., removable/integrated/reconfigurableeye cover or ear piece, different colors (color contrast), patterns,and/or surface texture).

In FIG. 16-1, the sealing arrangement 1220 of the full-face patientinterface 1210 is adapted to provide a seal with the patient's nose andmouth. As illustrated, the sealing arrangement 1220 may include two ormore different materials (e.g., materials A and B as shown in FIG. 16-1)with different properties (e.g., surface texture, hardness, thickness,etc.) that contact the patient's nose, e.g., to improve seal and/orstability. The inlet conduit arrangement 1230 of the full-face patientinterface 1210 may also include two or more different materials (e.g.,materials C and D as shown in FIG. 16-1), e.g., for aesthetic reasonsand/or stability. In addition, an ear piece 1270 (e.g., audio piece, earplug) may be provided to the inlet conduit arrangement 1230 and adaptedto engage the patient's ear.

FIG. 16-2 is similar to FIG. 16-1 (and indicated with similar referencenumerals), but without the ear piece 1270.

FIG. 16-3 is similar to FIG. 16-1 (and indicated with similar referencenumerals), but without the ear piece 1270. Also, in this embodiment, thefull-face patient interface of FIG. 16-3 includes an eye cover 1275. Theeye cover 1275 may be separate from, retro-fit to, or integrated withthe sealing arrangement 1220 and/or inlet conduit arrangement 1230 ofthe full-face patient interface 1210. As illustrated, the eye cover 1275may include a different material than other portions of the interface,e.g., for aesthetic reasons and/or stability. In use, the eye cover 1275is structured to stop air getting into the patient's eyes. In anembodiment, the eye cover 1275 may be provided to the full-face patientinterface shown in FIG. 16-1.

FIGS. 16-4 to 16-14 illustrate lifestyle options for a nasal patientinterface (e.g., removable/integrated/reconfigurable eye cover and/orear piece, chin strap, different colors (color contrast), patterns,and/or surface texture).

In FIG. 16-4, the sealing arrangement 1320 of the nasal patientinterface 1310 is adapted to provide a seal with the patient's nose. Asillustrated, the sealing arrangement 1320 may include two or moredifferent materials (e.g., materials A and B as shown in FIG. 16-4) withdifferent properties (e.g., surface texture, hardness, thickness, etc.)that contact the patient's nose, e.g., to improve seal and/or stability.

A rear portion of the inlet conduit arrangement 1330 includes two ormore different materials (e.g., materials C and D as shown in FIG. 16-4)with different properties that contact the rear of the patient's head.As illustrated, a strip of material C is provided between upper strap1331 and lower strap 1333 to keep the straps 1331, 1333 apart andimprove stability. In addition, the strip of material C is constructedof a suitable material so that it does not crush the patient's hair inuse. The strip of material C may include opacity, e.g., for aestheticreasons.

Also, the nasal patient interface 1310 includes a chin strap 1380. Asillustrated, ends 1381 of the chin strap 1380 are provided to portionsof the inlet conduit arrangement 1330 that are proximal to the sealingarrangement 1320. The chin strap 1380 may be separate from, retro-fitto, or integrated with the inlet conduit arrangement 1330. In use, thechin strap 1380 is structured to engage under the patients chin (e.g.,and close the patient's mouth) and create vectors to improve stabilityof the nasal patient interface 1310 on the patient's head.

FIG. 16-5 is similar to FIG. 16-4 (and indicated with similar referencenumerals). In contrast, ends 1381 of the chin strap 1380 are provided toportions of the inlet conduit arrangement 1330 that are distal from thesealing arrangement 1320.

FIG. 16-6 is similar to FIG. 16-4 (and indicated with similar referencenumerals), but without the chin strap 1380. Also, in this embodiment,the nasal patient interface of FIG. 16-6 includes an ear piece 1370(e.g., audio piece, ear plug) provided to the inlet conduit arrangement1330 and adapted to engage the patient's ear.

FIG. 16-7 is similar to FIG. 16-4 (and indicated with similar referencenumerals), but without the chin strap 1380.

FIG. 16-8 is similar to FIG. 16-4 (and indicated with similar referencenumerals), but without the strip of material C between upper strap 1331and lower strap 1333. In this embodiment, the upper strap 1331 isconstructed of material E having different properties (e.g., surfacetexture, hardness, thickness, etc.) than material D of lower strap 1333,e.g., for aesthetic reasons and/or stability.

FIG. 16-9 is similar to FIG. 16-8 (and indicated with similar referencenumerals), but without the chin strap 1380.

FIG. 16-10 is similar to FIG. 16-8 (and indicated with similar referencenumerals), but without the chin strap 1380. Also, in this embodiment,the nasal patient interface of FIG. 16-10 includes an ear piece 1370(e.g., audio piece, ear plug) provided to the inlet conduit arrangement1330 and adapted to engage the patient's ear.

FIG. 16-11 is similar to FIG. 16-8 (and indicated with similar referencenumerals). In contrast, ends 1381 of the chin strap 1380 are provided toportions of the inlet conduit arrangement 1330 that are distal from thesealing arrangement 1320, e.g., similar to the chin strap shown in FIG.16-5.

FIG. 16-12 is similar to FIG. 16-8 (and indicated with similar referencenumerals), but without the chin strap 1380. Also, in this embodiment,the nasal patient interface of FIG. 16-12 includes an eye cover 1375,e.g., similar to the eye cover shown in FIG. 16-3.

FIG. 16-13 is similar to FIG. 16-8 (and indicated with similar referencenumerals), but without the chin strap 1380. Also, in this embodiment,the upper and lower straps 1331, 1333 are constructed of a similarmaterial E, which have different properties (e.g., surface texture,hardness, thickness, etc.) than material D of side strap 1335. Forexample, materials E and D may be different materials or colors forfunctional or aesthetic purposes. In an embodiment, material E may beconstructed of a material that includes coloring similar to thepatient's hair color to blend in with the patient's head, aidsstability, rigidity, and/or gripping, is breathable, and/or aidsintuitiveness for ease of fitting (e.g., identifies back to front and/orupside-down).

FIG. 16-14 is similar to FIG. 16-4 (and indicated with similar referencenumerals), but without the chin strap 1380. Also, in this embodiment,the nasal patient interface of FIG. 16-14 includes an eye cover 1375,e.g., similar to the eye cover shown in FIG. 16-3.

FIGS. 16-15 to 16-23 illustrate lifestyle options that may or may not beincorporated into patient interfaces (e.g.,removable/integrated/reconfigurable eye cover or ear piece, rear straparrangements).

FIG. 16-15 illustrates an interface 1410 for a bed partner of a patientreceiving respiratory therapy. That is, the interface 1410 is structuredto enhance sleep and does not provide breathable gas to the nose and/ormouth of the bed partner. However, it should be appreciated that theinterface may be suitably modified to include structure for supplyingbreathable gas.

In the illustrated embodiment, the interface 1410 includes a straparrangement including an upper strap 1431 that passes over the top ofthe bed partner's head and a lower strap 1433 that passes under the bedpartner's ears and behind a lower portion of the bed partner's head. Anear piece 1470 (e.g., audio piece, ear plug) is provided to the straparrangement and is adapted to engage the bed partner's ear. Also, an eyecover 1475 is provided to the strap arrangement. As illustrated, the eyecover 1475 and upper strap 1431 may include a different material withdifferent properties than that of the lower strap 1433 and ear piece1470, e.g., for aesthetic reasons and/or stability.

FIG. 16-16 is similar to FIG. 16-15 (and indicated with similarreference numerals), but without the eye cover 1475.

FIG. 16-17 illustrates a strap arrangement 1530 for a patient interface.As illustrated, the strap arrangement includes an upper strap 1531 thatpasses over the top of the patient's head and a lower strap 1533 thatpasses under the patient's ears and behind a lower portion of thepatient's head. An air delivery conduit 1505 is provided to the upperstrap 1531 at the top of the patient's head. In the illustratedembodiment, the air delivery conduit 1505 may be coupled to the upperstrap 1531 by a manifold 1532 adapted to rotate about its longitudinalaxis, e.g., transverse to the upper strap 1531 at the top of thepatient's head. The upper strap. 1531 may be constructed of a materialhaving different properties (e.g., surface texture, hardness, thickness,etc.) than a material of the lower strap 1533, e.g., for aestheticreasons and/or stability. Such strap arrangement may enhance patientcomfort because no strap extends across the back of patient's headand/or different vectors are provided for stability of seal.

FIG. 16-18 illustrates a strap arrangement 1630 for a patient interfaceincluding an upper strap 1631 that passes over the top of the patient'shead and a lower strap 1633 that passes over the patient's ears andbehind the patient's head. An air delivery conduit 1605 is provided tothe upper strap 1631 at the top of the patient's head, e.g., via amanifold 1632 similar to that in FIG. 16-17. Also, the upper and lowerstraps may be constructed of materials having different properties.

FIG. 16-19 illustrates a strap arrangement 1730 for a patient interfaceincluding an upper strap 1731 that passes over the top of the patient'shead and a lower strap 1733 that passes over the patient's ears andbehind the patient's head. An air delivery conduit 1705 is provided tothe upper strap 1731 at the top of the patient's head. In theillustrated embodiment, the air delivery conduit 1705 may be coupled tothe upper strap 1731 by a manifold 1732 adapted to rotate about an axisthat extends through coronal and transverse planes at the top of thepatient's head.

A strip of material C is provided between upper strap 1731 and lowerstrap 1733 to keep the straps 1731, 1733 apart and improve stability. Asillustrated, the strip of material C may be constructed of a materialhaving different properties (e.g., surface texture, hardness, thickness,etc.) than a material D of the upper and lower strap 1731, 1733, e.g.,for aesthetic reasons and/or stability.

FIG. 16-20 illustrates a strap arrangement 1830 for a patient interfaceincluding an upper strap 1831 that passes over the top of the patient'shead and a lower strap 1833 that passes under the patient's ears andbehind a lower portion of the patient's head. An air delivery conduit1805 is provided to the upper strap 1831 at the top of the patient'shead, e.g., via a manifold 1832 similar to that in FIG. 16-19. Also, astrip of material C extends from the upper strap 1831, e.g., forstability.

FIG. 16-21 illustrates a strap arrangement 1930 for a patient interfaceincluding an upper strap 1931 that passes over the top of the patient'shead and a lower strap 1933 that wraps around the patient's ears, i.e.,lower strap 1933 passes behind and under the patient's ears and towardsthe patient's face. A strip of material 1985 is provided to the lowerstrap 1933 adjacent each ear. As illustrated, the strip of material 1985extends across the front of the patient's ear to retain the lower strap1933 adjacent the patient's ear.

An air delivery conduit 1905 is provided to the upper strap 1931 at thetop of the patient's head, e.g., via a manifold 1932 similar to that inFIG. 16-19. Also, a rear strap 1990 extends across the back of thepatient's head, e.g., for stability. As illustrated, ends of the rearstrap 1990 are provided to a portion of the lower strap 1933 adjacenteach ear.

FIG. 16-22 is similar to FIG. 16-21 (and indicated with similarreference numerals), but without the rear strap 1990. In thisembodiment, the strap arrangement only uses the patient's ears toretain.

FIG. 16-23 illustrates a strap arrangement 2030 (e.g., for an interfacefor a patient and/or bed partner) including an upper strap 2031 thatpasses over the top of the patient's head and a lower strap 2033 thatpasses under the patient's ears and behind a lower portion of thepatient's head. An ear piece 2070 (e.g., audio piece, ear plug) isprovided to the strap arrangement and is adapted to engage the bedpartner's ear. The ear piece 2070 may help to retain the arrangement onthe patient's head. Also, the upper and lower straps 2031, 2033 may beconstructed of materials having different properties, e.g., forstability and/or aesthetics.

6. Additional Lifestyle Options

FIGS. 17A to 41B illustrate other exemplary lifestyle options or patientinterfaces to enhance and/or facilitate the treatment session.

In each embodiment described below, the inlet conduit arrangement mayinclude tubing, straps, and/or a cover to support the interface on thepatient's head and deliver breathable gas to the sealing arrangement.

For example, FIGS. 17A to 17C illustrate a patient interface 2110including a soft shield 2115 structured to flip up and flip down, e.g.,similar to a welder's helmet. A sealing arrangement 2120, e.g., nasalprongs, is provided to the shield 2115 and adapted to provide aneffective seal with the patient's nose when the shield 2115 is flippeddown (FIG. 17A). As shown in FIG. 17A, the sealing arrangement 2120 ishidden from view when the shield 2115 is flipped down. In addition, theshield 2115 provides an eye mask to enhance and/or facilitate thetreatment session as well as sleep. The shield 2115 may be flipped up(FIG. 17B) for quick vision.

An inlet conduit arrangement 2130 is communicated with the sealingarrangement 2120 and maintains the patient interface in an operativeposition on the patient's head. An air delivery conduit 2105 is attachedto the inlet conduit arrangement 2130, e.g., behind the patient's ear oneither side, as shown in FIG. 17C.

In an embodiment, the shield 2115 and/or inlet conduit arrangement 2130may be constructed of a soft silken quilted fabric with a flexiblestructure (e.g., TPE) sewn in for rigidity.

FIGS. 18A to 18F illustrate another embodiment of a patient interface2210 including a sealing arrangement 2220, e.g., nasal prongs 2222,adapted to provide an effective seal with the patient's nose, an inletconduit arrangement 2230 including inlet conduits 2237 (e.g., eachhaving a generally oval cross-sectional configuration) adapted todeliver breathable gas to the sealing arrangement 2220, and a cover 2240that substantially encloses the sealing arrangement 2220 and the inletconduit arrangement 2230 (e.g., cover 2240 structured to expose nasalprongs 2222 and manifold 2232 adapted to connect to an air delivery tube2205).

FIG. 18B illustrates the sealing arrangement 2220 and inlet conduitarrangement 2230 removed from the cover 2240, FIG. 18C is an isolatedview of the cover 2240, FIG. 18D illustrates the patient interface 2210with the conduits 2237 arranged in the cover 2240 so that the airdelivery tube 2205 extends from an upper strap of the cover 2240 at thetop of the patient's head in use, and FIG. 18E illustrates the patientinterface 2210 with the conduits 2237 arranged in the cover 2240 so thatthe air delivery tube 2205 extends from a bottom strap of the cover 2240at the bottom of the patient's head in use.

The patient interface 2210 provides a smooth, clean, one-piece structurewith no “dangling” tubes. The cover 2240 may include an outer shell 2241and an inner lining or insert 2243. The outer shell 2241 may be arelatively hard shell or a textile soft-touch cover, and the innerlining or insert 2243 may be a relatively soft and padded textile, e.g.,for comfort. The cover 2240 may be stain resistant and/or washable.Also, the cover 2240 may include a two-tone color scheme (e.g., with acompany logo). In addition, the cover 2240 may provide an extra softportion 2245 adjacent the patient's ears, e.g., for comfort.

The cover 2240 may include one or more adjustors 2225 that allow thesize of a strap of the cover to be adjusted for fit and comfort. Asshown in FIG. 18F, the adjustor 2225 may be manually squeezed or pressedand then slid along the strap to adjust the length of the strap. Thisarrangement provides an easy, clean strap adjustment. In addition, theadjustor 2225 may be relatively flexible or soft, e.g., for comfort.

FIGS. 19A to 19G illustrate another embodiment of a patient interface2310 including a sealing arrangement 2320, e.g., nasal prongs 2322,adapted to provide an effective seal with the patient's nose, an inletconduit arrangement 2330 including inlet conduits 2337 adapted todeliver breathable gas to the sealing arrangement 2320, and a soft cover2340 that substantially encloses the sealing arrangement 2320 and theinlet conduit arrangement 2330.

FIG. 19A illustrates the patient interface 2310 positioned on thepatient's head, FIGS. 19B and 19C illustrate the patient interface 2310removed from the patient's head, and FIG. 19D illustrates the sealingarrangement 2320 and inlet conduit arrangement 2330 (e.g., the CPAPassembly) removed from the cover 2340. In the illustrated embodiment,the cover 2340 includes ear pieces 2370 (e.g., audio pieces, ear plugs,noise reduction) that are adapted to engage the patient's ears and helpto maintain the patient interface in an operative position on thepatient's head. In an embodiment, at least one of the ear pieces 2370may provide a locking mechanism adapted to lock or block the flow of airpassing through the adjacent inlet conduit to the sealing arrangement,e.g., so that air flows down only one of the inlet conduits in use.

When the sealing arrangement 2320 and inlet conduit arrangement 2330(e.g., the CPAP assembly) is removed from the cover 2340, the cover 2340alone may be used as an interface for a bed partner to enhance sleep(e.g., CPAP assembly may be removed leaving the functionality of apartner version). For example, FIG. 19E illustrates a partner versionwith the cover 2340 and an eye mask 2375 provided to the cover 2340(e.g., eye mask clips to cover or attaches via Velcro), and FIG. 19Fillustrates a partner version without an eye mask. FIG. 19G illustratesa partner version with a filter 2390 adapted to engage the patient'snose and/or mouth, e.g., partner version that does not providepressurize air but does provide filtered or clean air.

FIGS. 20A to 20D illustrate another embodiment of a patient interface2410 including a sealing arrangement 2420 adapted to provide aneffective seal with the patient's nose and an inlet conduit arrangement2430 adapted to deliver breathable gas to the sealing arrangement 2420.A soft cover may substantially enclose the sealing arrangement 2420 andthe inlet conduit arrangement 2430.

As illustrated, the inlet conduit arrangement 2430 includes inletconduits 2437 that pass across the patient's cheeks, wrap behind thepatient's ears, and pass over the top of the patient's head. Suchconduit arrangement avoids pressure points or sensitive facial regions,e.g., cheek bones. A strip of material 2485 extends across the front ofthe patient's ear to retain the interface in an operative position.

The sealing arrangement 2420 provides an upper portion 2421, e.g.,constructed of a breathable material, that passes over an upper portionof the nose and a lower portion 2423 that covers the nose and provides aseal. Such arrangement avoids “medical” image presented by known masks,

As shown in FIG. 20D, an adjustor 2425 may be provided along theconduit. The adjustor 2425 may be manually squeezed or pressed and thenslid along the conduit to adjust the length of the strap.

In an embodiment, the conduits 2437 may constructed of ultra thin tubingto provide a streamlines interface. Such arrangement improvesaesthetics, which results in improved compliance by the patient.

FIG. 20B illustrates the patient interface 2410 with an eye mask orvisor attachment 2475, and FIG. 20C illustrates the patient interface2410 with ear pieces 2470 (e.g., audio pieces or headphones, ear plugs).

FIGS. 21A to 21C and 22 illustrate another embodiment of a patientinterface 2510 that provides two products in one (e.g., with no “addons”). Specifically, the patient interface 2510 may be in the form of anasal interface or nasal mask adapted to provide pressurized air to thepatient's nose (e.g., see FIGS. 21A and 22), or the patient interface2510 may be in the form of an eye mask (e.g., see FIG. 21B), e.g., nasalmask converted to eye mask by removing the nasal prong arrangement 2522provided within the interface cover 2540. FIG. 21C illustrates thepatient interface 2510 removed from the patient's head.

In each configuration, the patient interface 2510 provides ear pieces2570 or ear-located headgear that is adapted to engage the patient's earand retain the interface on the patient's head. In an embodiment, suchear pieces may also provide audio, ear plug, etc. Also, portions of thepatient interface (e.g., portions adjacent the patient's eyes in use)may provide moisturizing aspects in use.

FIGS. 23A to 23C illustrate another embodiment of a patient interface2610 that provides a multi-function head band or retention system 2650.Specifically, the multi-function retention system 2650 is structured tosupport a selected one of multiple modular interfaces or sleep enhancingfeatures so that the patient interface can assume one of multipleconfigurations.

As illustrated, the retention system 2650 includes a front strap 2631that passes over the patient's nose, side straps 2633 that pass alongrespective sides of the patient's face, and a top strap 2635 that passesover the top of the patient's head.

FIG. 23A illustrates a nasal mask or interface 2622 provided to theretention system 2650, FIG. 23B illustrates an eye mask or visor 2675provided to the retention system 2650 with the nasal mask removed, andFIG. 23C illustrates a full-face mask or interface 2634 provided to theretention system 2650 (e.g., full-face mask 2634 may provide aromaticscents, a filter, and/or moisturizing aspects). However, it should beappreciated that the retention system 2650 may support other modularinterfaces (e.g., pillows, prongs, nasal cradle) or sleep enhancingfeatures (e.g., ear pieces).

FIG. 24A illustrates another embodiment of a patient interface 2710including a sealing arrangement 2720 supported by lower side straps2731, upper side straps 2733, and a vertical strap 2735 that connectsthe upper and lower side straps 2731, 2733.

The upper, lower, and vertical straps 2731, 2733, 2735 may be a onepiece integrated structure, e.g., formed of textile. In use, thevertical strap 2735 provides a vertical vector, e.g., to aid stabilityand sealing. The patient interface 2710 provides a sleek, close to face,out of line of sight, and hence unobtrusive interface.

FIGS. 24B and 24C illustrate a patient interface similar to that shownin FIGS. 21A to 21C and 22 (and indicated with similar referencenumerals). As illustrated, the patient interface 2520 provides a simple,one-wrap band design that uses the patient's ears to provide verticalretention. FIG. 24C provides a view of the air delivery tube 2505 andthe sealing arrangement 2520.

FIG. 25A illustrates another embodiment of a patient interface 2810including an inlet tube 2837 that provides a seal or interface with thepatient's nose and wraps around an upper portion of the patient's neck,and a single thin strap 2839 that extends from the inlet tube 2837 andpasses over the top of the patient's head to secure the inlet tube 2837on the patient's head. The inlet tube 2837 itself also forms a strap tosecure the interface in position. In an embodiment, the inlet tube 2837may be constructed of a relatively soft textile material that is adaptedto flatten for comfort, e.g., like a fire hose, so that the patient maylie on one side of the tube while the other side provides a sufficientsupply of gas.

FIG. 25B illustrates another embodiment of a patient interface 2910including a flexible adjustable support 2990 provided to one of theinlet tubes 2937 thereof. As illustrated, the flexible adjustablesupport 2990 includes first and second arms 2991(1), 2991(2) with firstand second soft pads 2992(1), 2992(2) at respective distal ends. Thefirst arm 2991(1) is arranged so that the first pad 2992(1) engages thepatient's forehead, and the second arm 2991(2) is arranged so that thesecond pad 2992(2) engages the patient's cheek. However, other suitablepad arrangements are possible.

FIG. 25C illustrates a single-sided patient interface 3010 in which sidestraps and head/neck pads 3091 are provided to one side of the patient'shead.

FIG. 25D illustrates another embodiment of a patient interface 3110which incorporates a sleeping mask 3175 as well as a sealing arrangement3120 adapted to provide a seal with the patient's nose. An inlet opening3107 is provided to a rear portion of the interface and allows air toenter the interface and travel along a hidden tube in the interface tothe sealing arrangement 3120.

FIGS. 26A to 26B illustrates another embodiment of a patient interface3210 that is incorporated into a pillow 3295, e.g., soft fabric pillow.As illustrated, the patient interface 3210 includes an elongated arm3237 that is suitably contoured or bent so that the arm 3237 is adaptedto wrap around one side of the patient's face as the patient lies on thepillow 3295. The distal end of the arm 3237 supports a sealingarrangement, e.g., nasal interface, and an inlet tube is hidden withinthe arm. The arm 3237 may be spring biased so that it fits tightlyaround the patient's face and effects a seal.

The proximal end of the arm 3237 is provided to the pillow 3295 andadapted to communicate with an air delivery tube. In an embodiment, thepillow 3295 may include an inlet opening 3297 that allows the inlet tubeto communicate with an external air delivery tube. In anotherembodiment, the air delivery tube, air pump, and optional filter may bemay be housed within the pillow 3295.

FIG. 27 illustrates another embodiment of a patient interface 3310 whichincludes a soft, floppy hood or headwear 3315 that extends over the topof the patient's head. The hood 3315 encloses or hides the straparrangements or tubing of the interface. As illustrated, the airdelivery conduit 3305 protrudes from a floppy, rear portion of the hood3315.

FIGS. 28A to 28C illustrate a patient interface 3410 including a hood3415 that can be pulled over the top of the patient's head as well as anose/mouth cover 3417 that can be pulled over the patient's nose andmouth. The hood 3415 and nose/mouth cover 3417 encloses or hides thestrap arrangement, tubing, and seal arrangement of the interface so notubing or “hard” parts are visible on the patient's head.

FIG. 29A illustrates another embodiment of a patient interface 3510including a sealing arrangement 3520, e.g., over the nose seal orinterface, adapted to provide an effective seal with the patient's nose,inlet conduits 3537 adapted to deliver breathable gas to the sealingarrangement 3520, and an elastic strap 3531 that passes over thepatient's head to help maintain the patient interface in an operativeposition. The patient interface 3510 also includes ear pieces 3570(e.g., audio pieces, ear plugs, noise reduction) that are adapted toengage the patient's ears and help to maintain the patient interface inan operative position on the patient's head. In an embodiment, the inletconduits 3537 may be constructed of a clear material, e.g., to blendinto the patient's face.

FIGS. 29B and 29C illustrate another embodiment of a patient interface3610 including a sealing arrangement 3620 adapted to provide aneffective seal with the patient's nose, inlet conduits 3637 adapted todeliver breathable gas to the sealing arrangement 3620, and an upperstrap 3631 that passes over the patient's head and an intermediate strap3633 (extending between the upper strap 3631 and the conduit 3637) tohelp maintain the patient interface in an operative position. As shownin FIG. 29C, the sealing arrangement 3620 is in the form of an under thenose seal or interface (e.g., nasal inserts 3622) that provide lessvisual bulk of the interface and surrounding mask architecture.

FIG. 29D illustrates an embodiment of a patient interface 3710 whereinthe sealing arrangement 3720 and inlet conduit arrangement 3730 (e.g.,the CPAP assembly) are removably coupled to the cover 3740.

FIG. 30A illustrates another embodiment of a patient interface 3810including a sealing arrangement 3820, e.g., over the nose seal orinterface, adapted to provide an effective seal with the patient's nose,and a strap arrangement to maintain the sealing arrangement 3820 in anoperative position. The strap arrangement includes a forehead strap 3831that extends across the patient's forehead and side straps 3833 thatextend along the patient's cheeks and up towards the forehead strap 3831at the top of the patient's ears. Also, an optional linking strap 3835may extend between the forehead strap 3831 and an upper portion of thesealing arrangement 3820. In an embodiment, the straps 3831, 3833, 3835may include multi-plane rigidizers, e.g., formed from a rigid,thermo-formed structure.

FIG. 30B illustrates a patient interface 3810 with eye glasses or an eyecover 3875, and FIG. 30C illustrates the patient interface 3810 with eyeglasses or an eye cover 3875 along with a chin strap 3880.

FIG. 30D illustrates another embodiment of a patient interface 3910including a sealing arrangement 3920, e.g., over the nose seal orinterface, adapted to provide an effective seal with the patient's nose,and a strap arrangement to maintain the sealing arrangement 3920 in anoperative position. The strap arrangement includes a forehead strap 3931that extends across the patient's forehead and side straps 3933 thatextend along the patient's cheeks and under the patient's ears. Also, alinking strap 3935 may extend between the forehead strap 3931 and anupper portion of the sealing arrangement 3920.

FIG. 30E illustrates another embodiment of a patient interface 4010including a sealing arrangement 4020, e.g., over the mouth and nose sealor full-face interface, adapted to provide an effective seal with thepatient's mouth and nose, and a strap arrangement to maintain thesealing arrangement 4020 in an operative position. The strap arrangementincludes a forehead strap 4031 that extends across the patient'sforehead and a linking strap 4035 that extends between the foreheadstrap 4031 and an upper portion of the sealing arrangement 4020.

FIGS. 31A to 31E illustrate embodiments of patient interfaces having a“ski-mask” type structure adapted to wrap closely around the patient'seyes and nose. As shown in FIG. 31A, the patient interface 4110 includesa sealing arrangement 4120, e.g., under the nose seal or interface,adapted to provide an effective seal with the patient's nose, and astrap arrangement to maintain the sealing arrangement 4120 in anoperative position. The strap arrangement includes an upper strap 4131that extends across a lower portion of the patient's forehead (e.g.,just above the patient's eyebrows) and side straps 4133 that extendalong an upper portion of the patient's cheeks and up towards theforehead strap 4131 at the top of the patient's ears. FIG. 31Billustrates the patient interface 4110 with prescription eye glasses oran eye cover 4175 (e.g., for sleeping) attached thereto, e.g., clip-ineye glasses or eye cover.

In FIG. 31C, the patient interface 4210 includes a sealing arrangement4220, e.g., over the nose seal or interface, adapted to provide aneffective seal with the patient's nose, and a strap arrangement tomaintain the sealing arrangement 4220 in an operative position. Thestrap arrangement includes an upper strap 4231 that extends across alower portion of the patient's forehead (e.g., just above the patient'seyebrows) and side straps 4233 that extend along an upper portion of thepatient's cheeks and up towards the forehead strap 4231 at the top ofthe patient's ears. As illustrated, a logo 4206, e.g., company logo, maybe provided to a side of the interface. FIG. 31D illustrates the patientinterface 4210 with a linking strap 4235 extending between the foreheadstrap 4231 and an upper portion of the sealing arrangement 4220. Suchlinking strap 4235 provides vertical vectors for seal retention. In anembodiment, eye glasses or an eye cover may be attached to theinterface, e.g., similar to FIG. 31B.

FIG. 31E illustrates a patient interface 4310 with a similar structureto that shown in FIG. 31C. In contrast, the patient interface 4310 ofFIG. 31E may provide additional lining 4348 along the side straps.

FIG. 32A illustrates a patient interface 4410 including a sealingarrangement 4420, e.g., over the nose seal or interface, adapted toprovide an effective seal with the patient's nose, and a stabilizingarrangement to maintain the interface in a stable and secure position onthe patient's head. The stabilizing arrangement includes a cap portion4431 that conforms to the top of the patient's head, side straps 4433that wrap around the patient's eyes to the sealing arrangement 4420, anda linking strap 4435 extending between the cap portion 4431 and an upperportion of the sealing arrangement 4420.

FIG. 32B illustrates a patient interface 4510 with a less obtrusiveconfiguration, e.g., compared to FIG. 32A. As illustrated, the patientinterface 4510 includes a sealing arrangement 4420, e.g., under the noseseal or interface, adapted to provide an effective seal with thepatient's nose, and a strap arrangement to maintain the sealingarrangement 4520 in an operative position. The strap arrangementincludes an upper strap 4531 that extends upwardly from the sealingarrangement 4520 and over the top of the patient's head, and side straps4533 that extend along the patient's cheeks towards the patient's ears.In this embodiment, the end of the side straps 4533 are adapted to wraparound the patient's ears, e.g., like sunglasses frames.

FIG. 32C illustrates a patient interface 4610 including a sealingarrangement 4620, e.g., over the nose seal or interface, adapted toprovide an effective seal with the patient's nose, and a straparrangement to maintain the sealing arrangement 4620 in an operativeposition. The strap arrangement includes an upper strap 4631 thatextends across the patient's forehead and over the top of the patient'shead, side straps 4633 that extend along the patient's cheeks towardsthe patient's ears, and a linking strap 4635 that extends between theupper strap 4631 and an upper portion of the sealing arrangement 4620.In this embodiment, the end of the side straps 4633 are adapted to wraparound the patient's ears, e.g., like sunglasses frames. Also, thelinking strap 4635 fits intimately to the patient's skin and provides alow profile so that the patient cannot see the interface in the field ofview.

FIG. 33A illustrates a patient interface 4710 including a sealingarrangement 4720, e.g., over the mouth and nose seal or full-faceinterface, adapted to provide an effective seal with the patient's mouthand nose, and a strap arrangement to maintain the sealing arrangement4720 in an operative position. The strap arrangement includes a foreheadstrap 4731 that extends across the patient's forehead, and side straps4733 that extend along the patient's cheeks towards the patient's ears.As illustrated, the interface wraps around the patient's chin to providechin support. Also, a nose piece 4771 is provided to the sealingarrangement and adapted to pinch the patient's nose. A cooling system4773 (e.g., fan device, cool pack, phase change material) may beprovided to a side of the interface for cooling the patient's face inuse.

The patient interface 4710 may be structured such that adaptable orretrofitable accessories may be attached to the interface. For example,FIG. 33B illustrates an eye mask 4775 that may be attached to theinterface (e.g., eye mask clips onto interface with magnets), and a pad4776 that may be attached to a lower portion of the interface. Such pad4776 may be structured to improve comfort and may include moisturizersand/or aromas (e.g., dry powder, scents, cleansers, etc.)

FIG. 33C illustrates another embodiment of a patient interface 4810including a sealing arrangement 4820, e.g., over the nose seal orinterface, adapted to provide an effective seal with the patient's nose,and a strap arrangement to maintain the sealing arrangement 4820 in anoperative position. The strap arrangement includes side straps 4831 thatextend along the patient's cheeks towards the patient's ears, and anupper strap 4833 that passes over the patient's head. In an embodiment,the side straps 4831 and sealing arrangement 4820 may be constructed ofa clear material, e.g., to provide an “invisible” mask that blends intothe patient's face. However, the sealing arrangement 4820 may beconstructed of a material having white coloring, e.g., to hide steam.Also, a logo 4806, e.g., company logo, may be provided to a side strapof the interface.

FIG. 34A illustrates another embodiment of a patient interface 4910including a sealing arrangement 4920, e.g., over the mouth and nose sealor full-face interface, adapted to provide an effective seal with thepatient's mouth and nose, and a strap arrangement to maintain thesealing arrangement 4920 in an operative position. The strap arrangementincludes a rear cap portion 4931 that conforms to a rear portion of thepatient's head and side straps 4933 that extend along the patient'scheeks. In addition, the strap arrangement includes a cooling system orcooling cover 4935 that wraps around the patient's chin, jaw, and neck.The cooling system or cooling cover 4935 provides support for theinterface and includes climate control attributes, e.g., phase changematerials that provide a cooling effect in the summer and a warmingeffect in the winter.

FIG. 34B illustrates another embodiment of a patient interface 5010including a sealing arrangement 5020, e.g., over the nose seal orinterface, adapted to provide an effective seal with the patient's nose,and a strap arrangement to maintain the sealing arrangement 5020 in anoperative position. The strap arrangement includes a forehead strap 5031that extends across the patient's forehead and side straps 5033 thatextend along the patient's cheeks and under the patient's ears. Also, alinking strap 5035 extends between the forehead strap 5031 and an upperportion of the sealing arrangement 5020.

FIG. 35A illustrates another embodiment of a patient interface 5110including a sealing arrangement 5120, e.g., over the mouth and nose sealor full-face interface, adapted to provide an effective seal with thepatient's mouth and nose, and a strap arrangement to maintain thesealing arrangement 5120 in an operative position. The strap arrangementincludes side straps 5131 that extend over the patient's ears, and anupper strap 5133 that passes over a rear portion of the patient's head.As illustrated, the sealing arrangement 5120 wraps around the front ofthe patient's face, e.g., over the patient's nose, mouth, chin, andcheeks.

FIG. 35B illustrates another embodiment of a patient interface 5210including a sealing arrangement 5220, e.g., over the nose seal orinterface, adapted to provide an effective seal with the patient's nose,and a strap arrangement to maintain the sealing arrangement 5220 in anoperative position. The strap arrangement includes side straps 5231 thatextend around the patient's ears (e.g., opening provided in strap toreceive respective ear), and an upper strap 5233 that passes over a rearportion of the patient's head. As illustrated, the sealing arrangementand strap arrangement may formed as a one-piece, semi-rigid structurethat is adapted to clip onto the patient's face and head, e.g., likeheadphones.

FIGS. 36A and 36B illustrate a patient interface 5310, e.g., adapted toprovide an under the nose seal or interface, and a pillow accessory 5311provided to the patient interface 5310. In an embodiment, the pillowaccessory 5311 may be an inflatable air pillow or plenum. Asillustrated, the pillow accessory 5311 is structured to wrap around thepatient's neck to support the interface on the patient's head as well assupport the patient's head or neck, e.g., during a plane trip.

FIG. 36C illustrates a patient interface 5410, e.g., adapted to providean under the nose seal or interface, and a head covering or balaclava5413 provided to the patient interface 5410. The head covering orbalaclava 5413 provides a close-fitting covering for the patient's headand neck, e.g., for warmth, that leaves only the patient's eyes exposed.FIG. 36D illustrates the patient interface 5410 with the head coveringor balaclava 5413 removed.

FIG. 37A illustrates another embodiment of a patient interface 5510including a sealing arrangement 5520, e.g., over the nose seal orinterface, adapted to provide an effective seal with the patient's nose,and a strap arrangement to maintain the sealing arrangement 5520 in anoperative position. The strap arrangement includes side straps 5531 thatextend over the patient's ears, and a rear cap portion 5533 that coversa rear portion of the patient's head. As illustrated, the rear capportion 5533 may provide a cooling system or cooling cover that includesclimate control attributes, e.g., phase change materials.

FIG. 37B illustrates the patient interface 5510 with an additional uppercap portion 5535 that covers an upper portion of the patient's head. Theupper cap portion 5535 may provide a cooling system or cooling coverthat includes climate control attributes, e.g., phase change materials.

FIG. 37C illustrates the patient interface 5510 enclosed by a head cover5540 that covers the patient's head and leaves only the patient's eyesexposed. The cover 5540 provides stability, e.g., like a helmet, whileit wraps around the patient's skull and provides an intimate fit. A nosepiece 5571 may be provided to the cover 5540 and adapted to pinch thepatient's nose. In an embodiment, the cover 5540 may be removed to allowventilation, without affecting stability.

FIG. 37D illustrates the interface 5510 and head cover 5540 of FIG. 37Cwith additional accessories, such as an eye shade 5575, ear pieces 5570(e.g., for music), and a lower cover 5576 for the patient's mouth andchin.

FIG. 38A illustrates another embodiment of a patient interface 5610including a relatively loose hood 5615 that can be pulled over the topof the patient's head, e.g., for warmth. The hood 5615 hides andsupports tubing 5637 (e.g., without providing marks on the patient'sface) that delivers breathable air to nasal prongs or inserts 5622,e.g., foam nasal prongs adapted to provide an interference fit insidethe patient's nose. As illustrated, the tubing 5637 extends fromrespective sides of the hood 5615.

FIG. 38B illustrates the patient interface 5610 with the tubing 5637extending from a lower edge of the hood 5615.

FIG. 38C illustrates the patient interface 5610 with the hood 5615having a more tight or conforming fit to the patient's head. Forexample, the hood 5615 may be provided with cinching straps to tightenthe hood on the patient's head.

FIG. 38D illustrates a patient interface 5710 including a hood 5715 thatprovides a close-fitting covering for the patient's head and neck thatleaves only the patient's eyes exposed.

FIG. 38E illustrates a hood 5815 that may be retrofit to a patientinterface 5810, e.g., adapted to provide an over the mouth and nose sealor full-face interface.

FIG. 39A illustrates another embodiment of a patient interface 5910including ear pieces 5970 adapted to engage the patient's ears, andtubes 5937 extending from respective ear pieces 5970 and adapted todeliver breathable air to nasal prongs or inserts 5922. The tubes 5937are structured to wind-up into respective ear pieces 5970 to providepersonalized fitting (e.g., length of tubes can be selectively adjusted)and storage (e.g., tubes can be completely wound up into respective earpieces 5970).

FIGS. 39B and 39C illustrate another embodiment of a patient interface6010 including ear pieces 6070 adapted to engage the patient's ears, andtubes 6037 extending from respective ear pieces 6070 and adapted todeliver breathable air to nasal prongs or inserts 6022. As illustrated,the tubes 6037 are relatively long so that they hang downwardly from thepatient's face without providing marks on the patient's face. Inaddition, the patient's face is more open as the interface providesminimal coverage. As shown in FIG. 39C, the ear pieces 6070 are coupledto one another to provide a back-of-head clip, e.g., headphoneattachment. Also, the nasal prongs or inserts 6022 may be coupled to oneanother, e.g., by a connector 6023 as shown in FIG. 39C.

FIG. 39D illustrates another embodiment of a patient interface 6110including a single ear piece 6170 adapted to engage one of the patient'sears, and a single tube 6137 extending from the ear piece 6170 andadapted to deliver breathable air to a sealing arrangement, e.g., underthe nose seal or interface 6122. This arrangement provides a single tubeinterface with minimal coverage on the patient's face.

FIG. 40 illustrates another embodiment of a patient interface 6210including ear pieces 6270 adapted to engage the patient's ears, andtubes 6237 extending from respective ear pieces 6270 and adapted todeliver breathable air to a sealing arrangement, e.g., over the noseseal or interface 6222. As illustrated, the tubes 6237 are relativelylong or loose so that they hang downwardly from the patient's facewithout providing marks on the patient's face. In addition, thepatient's face is free of pressure points. In an embodiment, an adhesiveseal 6227 may be provided to the sealing arrangement to enhance the sealaround the patient's nose.

FIG. 41A illustrates another embodiment of a patient interface 6310including a head band or forehead strap 6331 that extends across thepatient's forehead and tubes 6337 extending from the forehead strap 6331and adapted to deliver breathable air to nasal prongs or inserts 6322.In an embodiment, nasal prongs or inserts 6322 may be snap-fit torespective tubes 6337, e.g., to facilitate replacement or cleaning.

FIG. 41B illustrates another embodiment of a patient interface 6410including neck mounted tubing. As illustrated, the patient interface6410 includes an annular neck tube 6431 adapted to wrap around thepatient's neck and inlet tubing 6433 that extends upwardly from the necktube 6431 and adapted to deliver breathable air to the sealingarrangement, e.g., under the nose seal or interface 6422.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. Further, each independent feature orcomponent of any given assembly may constitute an additional embodiment.In addition, while the invention has particular application to patientswho suffer from OSA, it is to be appreciated that patients who sufferfrom other illnesses (e.g., congestive heart failure, diabetes, morbidobesity, stroke, barriatric surgery, etc.) can derive benefit from theabove teachings. Moreover, the above teachings have applicability withpatients and non-patients alike in non-medical applications.

1. A patient interface comprising: a sealing arrangement adapted toprovide an effective seal with the patient's nose; an inlet conduitarrangement adapted to deliver breathable gas to the sealingarrangement; and a cover that substantially encloses the sealingarrangement and/or the inlet conduit arrangement.
 2. A patient interfaceaccording to claim 1, wherein the cover and/or the sealing arrangementincludes one or more portions constructed of a textile and/or foammaterial.
 3. A patient interface according to claim 1, wherein thesealing arrangement has a laminated or multi-layer construction.
 4. Apatient interface according to claim 1, wherein the sealing arrangementis adapted to seal under, around, and/or slightly within the patient'snose.
 5. A patient interface according to claim 1, wherein the sealingarrangement is in the form of a nasal cradle, nasal cushion, or nasalprongs.
 6. A patient interface according to claim 1, wherein the sealingarrangement includes a leaky seal to allow breathing, avoid moisture,and/or allow gas washout.
 7. A patient interface according to claim 1,wherein the cover and/or inlet conduit arrangement, and in particularthe surface that engages the patient's face/head, is modeled from across-section of a elliptically shaped conic member.
 8. A patientinterface according to claim 7, wherein the cross-section has a widththat defines a tapered surface adapted to engage the patient's head. 9.A patient interface according to claim 8, wherein the tapered surfaceconverges in a direction forward of the patient's face.
 10. A patientinterface according to claim 1, wherein the cover incorporates one ormore regions having different colors, color contrast, patterns, and/orsurface texture.
 11. A patient interface according to claim 10, whereinthe cover has a two-tone color scheme.
 12. A patient interface accordingto claim 1, wherein the patient interface provides minimal adjustment.13. A patient interface according to claim 12, wherein the patientinterface provides one or no adjustment points.
 14. A patient interfaceaccording to claim 1, wherein the cover and/or inlet conduit arrangementhas a contour that blends or forms an organic extension of the patient'sface/head.
 15. A patient interface according to claim 14, wherein thecover and/or inlet conduit arrangement is non-circular or tapered.
 16. Apatient interface according to claim 1, wherein the inlet conduitarrangement integrally includes the cover.
 17. A patient interfaceaccording to claim 1, wherein the cover integrally includes the inletconduit arrangement.
 18. A method for fitting a patient interface to apatient comprising: locating a sealing portion of the patient interfacewith respect the patient's nose and/or mouth; and rotating or pivotingthe patient interface about the sealing portion onto the patient's headuntil the patient interface self locates onto the patient's head. 19.The method according to claim 18, further comprising adjusting a rearstrap of the patient interface to further secure the patient interfaceonto the patient's head.